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For active devices, see page 12f For special rules, see page 12g
4.2. General explanation of rules/Practical issues/Examples ........... APPENDICES : 1. Annex IX of the Medical Device Directive. 2. Decision tree .
http://www.gmcompliance.com/wp-content/uploads/Medical-Devices-Guidelines.pdf

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medical device directive decision tree

European Commission guidance documents
. covered by the medical devices directives or should be treated as medicines, . rules of the Medical Devices Directive, includes examples and decision trees.
http://www.bsigroup.com/en/ProductServices/Medical/Guidance-notes/European-commission/

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PRIMARY CARE

FINAL DOCUMENT
representatives from medical device regulatory agencies and the regulated industry. . Appendix A: Decision trees to demonstrate how the rules may be used to classify specific devices . (Source – based on European Directive 93/42 /EEC) .
http://www.ghtf.org/documents/sg1/SG1-N15-2006-Classification-FINAL.pdf


European Commission Publishes Guidance on Medical Software ...
Jun 27, 2012 . The MEDDEV guidance document addresses all of the medical device directives and includes two decision trees to determine whether .
http://www.ivdtechnology.com/article/european-commission-publishes-guidance-medical-software-used-ivds


Howard University Hospital

A practical Guide to understanding the scope of WEEE and RoHS.
Annex B: Application of the WEEE and RoHS decision trees . An infected medical device for the purpose of directive 2002/96/EC is any device or part of a .
http://www.schneider-electric.fr/documents/rohs/en/shared/rohs-orgalime-guide-en.pdf

The new EU MEDDEV on stand-alone software as medical device ...
Feb 2, 2012 . Since clinical decision support systems are software, much of what we write . First, you apply the tree for the Medical Devices Directive (which I .
http://medicaldeviceslegal.com/2012/02/02/the-new-eu-meddev-on-stand-alone-software-as-medical-device/


Title: Assistant professor of clinical family medicine at University of Illinois College of Medicine
Chicago, IL

Standalone Software Regulated As Medical Device: A Look Under ...
Oct 31, 2011 . I learned that the document will contain two convenient decision trees, one for stand alone software under the Medical Devices Directive (MDD) .
http://www.mondaq.com/x/151370/Software/Standalone+Software+Regulated+As+Medical+Device+A+Look+Under+The+Hood+Of+The+Draft+MEDDEV


Comparing EU and US Approaches to Regulating Clinical Decision ...
Mar 14, 2012 . Recently published guidance and, in particular, the decision trees it . But the forthcoming recast of the medical device directives may add a few .
http://www.emdt.co.uk/article/comparing-eu-and-us-approaches-regulating-clinical-decision-support-software-brief-summary-e

ASTHMA/PULMONARY MEDICINE

Decision tree | Enforcement | BIS
Category 8 - Medical devices. This list of products is taken from the WEEE Regulations. The list is not exhaustive but gives examples of the type of products .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories/medical-devices


83 KB - European Commission - Europa
Apr 11, 2012 . decision tree in Annex 1 can be used to identify whether a trial is a . object of the study is a medical device, Directive 2001/20/EC does not .
http://ec.europa.eu/health/files/eudralex/vol-10/ctqa_v10.pdf


Medical Device Classification
defense, medical devices, and clinical labs. – He holds a Masters . products within the scope of a New Approach Directive. . with decision trees. • Does not .
http://www.ombuenterprises.com/LibraryPDFs/Medical_Device_Classification.pdf


Specialty: Pediatric allergy and immunology

eHealthNews.eu Portal | COCIR Concept on Medical Software
Nov 23, 2010 . Since the revision of the European Medical Device Directive, in force. . The COCIR decision tree together with the explanatory text and .
http://www.ehealthnews.eu/industry/2370-cocir-concept-on-medical-software

CARDIOLOGY

THE MEDICAL DEVICES VIGILANCE SYSTEM REPORT
and implementation of the Directive for Active Implantable Medical Devices ( AIMD), . 5.2.4 The same considerations apply to a Competent Authority's decision . DECISION TREE – IDENTIFICATION OF RECALLS TO BE REPORTED BY .
http://www.salute.gov.it/imgs/C_17_pagineAree_90_listaFile_itemName_0_file.pdf


Medical Device Consultant and Regulatory Compliance
According to the European Medical Device Directive (93/42/EEC), a Medical Device is; . Further Clasification guidance and decision tree.......more.
http://www.mdqaconsultancy.co.uk/summary.html


President of American Association of Black Cardiologists
Morehouse School of Medicine
Atlanta, Georgia

COCIR Medical Software Qualification as Medical Device - 22 Nov ...
Nov 22, 2010 . medical domain qualifies as a medical device sub?ect to the requirements of European Directive. 93?42?EEC. Decision step 1: if the software .
http://www.cocir.org/uploads/documents/-48-cocir_medical_software_qualification_as_medical_device_-_22_nov_2010.pdf

MovinfLife Consul... - MovingLife
determined by a decision tree (placed in Annex IX of the Directive on Medical Device). There are four Risk Classes: Low - I, IIa, IIb, III – High. All medical devices .
http://www.moving-life.eu/downloads.php?cat_id=8&download_id=15


The Medical Device Regulatory System And Patient Safety
means of three directives: the Active Implantable Medical Device (AIMD), the Medical Device . devices into one of the four risk classes using a decision tree [ 4].
http://rahvatervis.ut.ee/bitstream/1/1970/9/Pallikarakis2006.pdf


Baltimore, MD

software used as medical devices
Jun 11, 2012 . The background is the revised Medical Device Directive. 2007/47 . devices"1, with definitions, eligibility criteria, decision trees and examples.
http://www.lakemedelsverket.se/upload/nyheter/2012/Introduction_to_MEDDEV_2.1-6_guidelines.pdf

NEUROLOGY

InfoMed - Makromed, Inc.: Complaint Handling and Adverse Event ...
Comply with FDA's GMP (QSR) and MDR regulations; Comply with European Union's Medical Device Directives (MDD); Use Decision Trees and Reporting .
http://www.makromed.com/product_infomed.html


RIVM briefrapport 680130002 In vitro diagnostic medical devices
draw a decision tree for IVD medical devices classification. . rules have been formulated within the Medical Device Directive to channel devices into the proper .
http://www.rivm.nl/bibliotheek/rapporten/360050007.pdf


If you have determined that your app is a medical device then the ...
Jan 17, 2012 . The Medical Device Directive 93/42/EEC (MDD) is the primary source . is shown by the following decision tree taken from a recent blog post.
http://campus2.univ-lille2.fr/claroline/backends/download.php?url=L0FyZV9hcHBzX21lZGljYWxfZGV2aWNlcy5kb2N4&cidReset=true&cidReq=APPSMED


Specialty: Neurosurgery

Report the functioning the Medical Devices Directive
Jun 5, 2002 . The report is mainly concerned with the Medical Devices Directive 93/42/EC. . The decision tree is based on a number of. Rules, which build .
http://www.jura.uni-augsburg.de/de/forschung/fmpr/download_gesetze/2002_06_05_Bericht_der_MDEG.pdf

NB-MED/2.13/Rec 1 - CE-Marking of pre-MDD devices
This document applies to Medical Devices which are placed on the market under the . regulations in Member States before the Medical Device Directive came into force. . Appendix 1 provides a decision tree which describes the process of .
http://www.bioingegneria.uniba.it/bollettino/attivita_enti_ing/nb_2_13rec1.htm

Regulation of health apps - a practical guide UPDATED
Jan 1, 2012 . The Medical Device Directive............................................................................................ . A recent blog post10 has shed light on a decision tree that .
http://www.d4.org.uk/research/regulation-of-health-apps-a-practical-guide-January-2012.pdf


Decision Tree for Questions on Clinical Trials Is your question - BASG
Jul 3, 2012. 5, A-1200 Wien. Decision Tree for Questions on Clinical Trials . including safety reports from CTs on medical devices? - Conduct of CTs on .
http://www.basg.gv.at/uploads/tx_basginfobox/L_Z25_Decision_Tree_for_Questions_on_Clinica_Trials_01.pdf


Los Angeles, CA

Public consultation on IVD Directive, 98/79/EC
the GHTF, it includes a single integrated Decision Tree for Risk Classification ( see . The directives on medical devices were written on the basis that the .
http://ec.europa.eu/health/medical-devices/files/ivd/108_ivd_en.pdf

DERMATOLOGY

Newly Updated European Classification Guidance | EMDT ...
Sep 14, 2010 . Determining the appropriate classification of a medical device is critically important. . use the rules” instead of “How to use the rules and the decision tree. . Table I: Amendments to the Medical Devices Directive (93/42/EEC) .
http://www.emdt.co.uk/article/newly-updated-european-classification-guidance


Annex B
Electronic Equipment (RoHS) Directive, new EEE containing more than the permitted levels of . versa. In particular, both Category 8 (medical devices) and Category 9 (monitoring . Go through the 'decision tree' and follow the guidance in .
http://www.environment-agency.gov.uk/static/documents/Business/EEE_Scope_Guidance_V3_0_March_2010_-_Final.pdf


MEDDEV Guidelines on Stand-Alone Medical Software Published
Jan 25, 2012 . Vollebregt: The decision trees and step-by-step instructions for qualification under the medical devices and IVD directive are really helpful.
http://medtechinsider.com/archives/26627


Specialty: Pediatric dermatology

Regulatory requirements for clinical investigations of medical devices
Medical device study decision tree for REC approval. 5. For specific advice . national laws a series of European medical device Directives framed in the. 1990s.
http://www.nres.nhs.uk/EasySiteWeb/GatewayLink.aspx?alId=11473

Consequences of the EU Ker-Optika Case for e-commerce in - EJBI
sumers, the medical devices directives1 presently do not. This makes the regulatory freedom . and COCIR's decision tree on software as medical de- vice at .
http://www.ejbi.org/img/ejbi/2012/2/Vollebregt_en.pdf


Are apps medical devices? Part two: Apps as ... - Pharmaphorum
Jan 24, 2012 . The Medical Device Directive 93/42/EEC (MDD) is the primary source of . Decision Support software will generally not be considered a medical . look is shown by the following decision tree taken from a recent blog post.
http://www.pharmaphorum.com/2012/01/24/6700/


Los Angeles, CA

RoHS Decision Tree Guidelines - Epsma
8. Medical devices and. - 9. Monitoring and control instruments (e.g. industrial measurement and automation technology). No. With following 'Decision tree' it´s .
http://www.epsma.org/pdf/decision_tree_RoHS_2005_11_21.pdf

ENDOCRINOLOGY

Vigiliance System
market before the medical device directive became effective are now subject to vigilance . Use an Incident Reporting Decision Tree. Create a decision tree to .
http://www.reuassociates.com/Vigilance_White_Paper.pdf


Donawa Lifescience Consulting - Training
Strategic planning and proper conduct of medical device clinical studies are not trivial . Special), what should be included in each, and how to utilize the FDA ' decision-tree'. . Directive 2007/47/EC: Revisions to the Medical Device Directives .
http://www.donawa.com/medical-device/content.php?ozim=66&tlt=Training


Youngstown, Ohio
Specialty: Reproductive endocrinology

Resource 4: Decision tree to establish whether a trial is a “clinical trial”
Resource 4: Decision tree to establish . A CLINICAL TRIAL OF A MEDICINAL PRODUCT? . Is it a medicinal . outside the scope of Directive 2001/20/EC. . A medical device. C.1. To discover or verify/compare its clinical effects? C.2.
http://www.crncc.nihr.ac.uk/Resources/NIHR%20CRN%20CC/Training/Resource%204%20NRES%20Decision%20Tree%20Adults%20lacking%20capacity%20to%20consent%20to%20research.pdf

WEEE Decision Tree Guidelines - EPSMA
might come within the scope of the WEEE directive (2002/96/EC): 9.*. Monitoring and control instruments. 8.*. Medical devices. Is the equipment part of another .
http://www.epsma.org/pdf/decision_tree_WEEE_2005_11_21.pdf


Restriction of Hazardous Substances (RoHS) directive
Medical Devices directive . Active Implantable Medical Devices . A good “ Decision Tree” walk-through of this process can be found on the NMO website.
http://www.conformance.co.uk/adirectives/doku.php?id=rohs


New Haven, CT
Specialty: Reproductive endocrinology

SG1/N015R15
6.3 Proposed General Classification System for Medical Devices 10. 7.0 The . Appendix A: Decision trees to demonstrate how the rules may be used to classify specific devices… . (Source – based on European Directive 93/42/EEC) .
http://www.team-nb.org/index.php?option=com_docman&task=doc_download&gid=83&Itemid=38&lang=en

HIV/AIDS

A BRIEF ON DIRECTIVE DECISION DEVICES
Directive decision devices can then come in two forms: (i). . Simple rule-based structures: Decision Tables and common Decision Trees . computer repairmen , emergency medical technicians and even some paraprofessionals (like the .
http://www.isy.vcu.edu/~jsutherl/Info691/DDD-TFSC-FINAL.doc


Recommendation NB-MED/2.5.2/Rec2 Reporting of design changes ...
The Medical Devices Directives variously require in different Annexes that where . 2 Manufacturer decision on whether or not particular changes are substantial .
http://www.meddev.info/_documents/R2_5_2-2_rev7.pdf


A Regulatory Primer
overcome before medical device products can be sold in . listed in the relevant medical devices Directive, . considered as a decision tree -- indeed, the official .
http://www.donawa.com/medical-device/donawa/files/A%20Regulatory%20Primer.pdf


Regulation and Compliance | IVD Technology
The MEDDEV guidance document addresses all of the medical device directives and includes two convenient decision trees to determine whether particular .
http://www.ivdtechnology.com/categories/regulation-and-compliance

MEDDEV 2.12/1 REV 6
EC-Directives on MEDICAL DEVICEs. They are legally not . used for self- testing where a medical decision may be made by the patient. Inadequacies in .
http://www.meddev.info/_documents/2_12_1-rev_6-12-2009_en.pdf


WEEE compliance | FAQs
The Directive on waste electrical and electronic equipment (WEEE) aims to . Medical devices (with the exception of all implanted and infected products); 9. . You should use the decision tree at Annex B to inform your final decision, but you .
http://www.complydirect.com/weee/faqs/


New York, NY

Software as a Medical Device - Part II
Since the 2007 amendment to the Medical Devices Directive (93/42/EC)1 aimed at . the decision framework, the guidance document contains a decision tree .
http://www.incompliancemag.com/index.php?option=com_content&view=article&id=1059:software-as-a-medical-device-part-ii&catid=27:testing&Itemid=136

INTERNAL MEDICINE

Regulation of Medical Apps FDA and European Union
Jul 21, 2011 . of 'medical device' under the Medical Devices Directive (MDD); Mobile . decision tree, the application serves up the information for medical .
http://www.medico-innovation.dk/wp-content/uploads/2011/10/JHW-Note-270711-Regulation-of-Medical-Apps-2.pdf


MANUAL OF DECISIONS FOR IMPLEMENTATION OF DIRECTIVE ...
DIRECTIVE 98/8/EC CONCERNING THE PLACING ON . used in In Vitro Diagnostic Medical. Devices .............................................................................. 22 .
http://ec.europa.eu/environment/biocides/pdf/mod.pdf


Methodist Hospital
Houston, Texas

HUMAN SUBJECT RESEARCH
B. Device Studies/Medical Classification of Devices 4 . DOD 3216.02 (http:// www.dtic.mil/whs/directives/corres/pdf/321602p.pdf), U.S. Food and Drug . To assess the application, please review the human subject use decision trees found at: .
https://cdmrp.org/files/forms/generic/Human_Subject_Research.doc

Understanding Medical Device Regulation for mHealth
GSMA is continuing to build its understanding of medical device regulation as it applies to . 2 According to Directive 2007/47/EC (21 March 2010) amendment to the . clear rules/decision trees for assessing predicates, which is an area that .
http://www.gsmworld.com/connectedliving/wp-content/uploads/2012/03/gsmaunderstandingmedicaldeviceregulationformhealthreport1.pdf


MedPass International Careers
. Development, Regulatory Strategies and EU Market Access for Medical Devices. . MEDPASS INTERNATIONAL MEDICAL DEVICE CRO - All rights reserved .
http://www.medpass.org/medical_careers.html


Bradley Merrill Thompson | LinkedIn
Medical Device and Drug Regulatory Attorney . Recently published guidance and, in particular, the decision trees it contains, can help . But the forthcoming recast of the medical device directives may add a few new twists and turns.
http://www.linkedin.com/in/bradleymerrillthompson

NEPHROLOGY

Businesses affected by the RoHS Regulations | Business Link
A new RoHS Directive will be published in the summer of 2011. . ceramic electronic (piezoelectronic) devices; medical devices including radiotherapy equipment . Use a decision tree to determine whether equipment is covered by the RoHS .
http://www.businesslink.gov.uk/bdotg/action/detail?itemId=1082901024&type=RESOURCES


Archives | IVD Technology
The MEDDEV guidance document addresses all of the medical device directives and includes two decision trees to determine whether software is regulated .
http://www.ivdtechnology.com/archives


Atlanta, GA
Grady Hospital

WEEE REGULATIONS
B Decision tree to assist interpretation of the scope of the Directive . Council Directive on Waste Electrical and Electronic Equipment . 8) Medical devices .
http://www.jeol.co.jp/envi/seminar/pdf/weeeguidance_draft.pdf

Draft Guidance for the Risk-based Classification System - 1998 ...
Feb 3, 2009 . The proposed Medical Devices Regulations set out the . Issues; 2.6 Dispute Resolution; 2.7 How to Use the Rules & the Decision Tree . from those which appear in the European Union's Council Directive 93/42/EEC.
http://www.hc-sc.gc.ca/dhp-mps/md-im/applic-demande/guide-ld/risk5_risque5-eng.php


medical devices vigilance
Implantable Medical Devices and the Medical Devices Directive. . The same considerations apply to a Competent Authority's decision whether to inform a manufacturer of an . Decision tree : identification of recalls to be reported by .
http://www.bioingegneria.uniba.it/bollettino/attivita_enti/meddev_2_12_1.htm


CE-Marking of pre-MDD devices - team-nb.org
Medical Device Directive but which were designed to comply with existing . decision tree which describes the process of demonstrating compliance to the .
http://www.team-nb.org/index.php?option=com_docman&task=doc_download&gid=1202&Itemid=38&lang=en


EU Guidance on Stand-Alone Software Used in IVD Applications ...
May 4, 2012. of definitions that link to Europe's medical device and IVD directives. . A decision tree contained within the report can be a huge help in .
http://www.ivdtechnology.com/blog/ivdt-insight/eu-guidance-stand-alone-software-used-ivd-applications

NEUROLOGY

Research: Projects - Medical Informatics
Jul 31, 2012 . This section describes fellows at the Yale Center for Medical . Research: Dr. Hajizadeh developed a decision tree of advance directives for . for treatment of asthma on a hand held computing device (an Apple Newton).
http://ycmi.med.yale.edu/research/rgraduates.html


Decision tree | Enforcement | BIS
This list of products is taken from the WEEE Regulations. The list is not exhaustive but gives examples of the type of products included in the broader category of .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories/monitoring-and-control-instrument


New York, NY

PROPOSED DOCUMENT
Proposed General Classification System for Medical Devices ................................ ... 10 . Appendix A: Decision trees to demonstrate how the rules may be used to classify specific devices. . (Source – based on European Directive 93/42/EEC) .
http://www.ghtf.org/documents/sg1/SG1(PD)N015.pdf

eHealth and clinicians « medicaldeviceslegal
Jan 13, 2011 . Medical devices legal and regulatory blog . or decision tree and produces a result based on that and serves up the information for medical . alone software”) and falling under the European Medical Device Directive (MDD).
http://medicaldeviceslegal.com/2011/01/13/ehealth-and-clinicians/


Private practice
Westhills Hospital; Northridge Hospital

Project about to be validated by Eur
The result of this recast is Directive 2011/65/EU (hereafter referred to as the “ Recast . Extension of the scope to medical devices and monitoring and . The following RoHS decision tree summarises all the criteria analysed in this Guide and .
http://rohs.exemptions.oeko.info/fileadmin/user_upload/Rohs_V/Orgalime_RoHS_Guide_-_July_2011.pdf


IA part 2 - European Commission - Europa
Mar 1, 2012 . Impact on the speed of pricing and reimbursement decisions . provided today by the medical devices directives concerning the quality of the .
http://ec.europa.eu/enterprise/sectors/healthcare/files/docs/impact_assessment_part2_en.pdf

OB-GYN

REPORT OF THE SG1 MEETING HELD ON 25-26 FEBRUARY
5 Report from the In Vitro Diagnostic Medical Devices Subgroup (IVD MD . a) Update on the 'recast' of the three European Directives for medical devices. . COCIR has prepared a draft 'decision tree' which was presented to SG1 by Peter .
http://www.ghtf.org/documents/sg1/sg1summary10052010.doc


Decision tree categories - BIS
Decision tree categories. . 8. Medical devices (with the exception of all implanted and infected products) · 9. Monitoring and control instruments · 10. Automatic .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories


Detroit, MI

Decision tree | Enforcement | BIS
This list of products is taken from the WEEE Regulations. The list is not exhaustive but shows examples of the type of products included in the broader category .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories/small-household-appliances

Feature Article | EMDT - European Medical Device Technology
European Medical Device Technology (EMDT) combines .
http://www.emdt.co.uk/department/feature-article


SG1/N015R15
6.3 Proposed General Classification System for Medical Devices 11 . Appendix A: Decision trees to demonstrate how the rules may be used to classify . (Source - European Directive 90/385/EEC – but modified to include accessories) .
http://www.ghtf.org/documents/sg1/pd_sg1_n015r22.doc


Position Papers - COCIR - The European Coordination Committee ...
COCIR Decision Tree on Classifying Medical Software - 22 November 2011 . Joint Industry Position on Recast of Medical Devices Directives (MDDs) - 2 July .
http://www.cocir.org/content.php?level1=16&mode=28

ONCOLOGY/HEMATOLOGY

Titel
3rd National Conference for Medical Devices, 13/14 April 2010, Rome . of Clinical Evaluation in the Revision of the Medical Device Directives 2007/47/ . Essential clinical investigation documents i; Adverse event classification decision tree i .
http://www.salute.gov.it/imgs/C_17_pagineAree_1678_listaFile_itemName_50_file.ppt


European Medical Device Technology, March/April 2012, Volume 3 ...
Recently published guidance and, in particular, the decision trees it contains, can . But the forthcoming recast of the medical device directives may add a few .
http://www.emdt.co.uk/epublish/8/33


New York, NY

Medical devices - European Commission
Directives on medical devices. They are legally not . How to use the rules and the decision tree . . The Medical Devices Directive states that as a general rule, .
http://ec.europa.eu/health/medical-devices/files/meddev/2_2_4-1part1_07-2001_en.pdf

Project Management
Mar 17, 2012 . clinical data pertaining to a medical device, to verify . 'The safety and performance of medical devices are . Adverse event decision tree: . furnish clinical data in line with the new European Directives that came into effect .
http://www.hsa.gov.sg/publish/etc/medialib/hsa_library/health_products_regulation/clinical_trials/files_1.Par.91303.File.tmp/Clinical%20Development%20of%20Medical%20Devices%20(15Mar2012).pdf


COCIR EUROM VI comments on Revision Regulatory Framework
Feb 27, 2012 . market and/or put into service” (Medical Devices Directive-. MDD Art. 2) - now . a decision tree along with several other clinical and technical .
http://www.cocir.org/uploads/documents/-66-cocir_eurom_vi_comments_on_revision-regulatory-framework-for_md_27_february_2012.pdf


Decision tree | Enforcement | BIS
Light bulbs and luminaires in households are excluded from WEEE but are included in RoHS. The RoHS Directive gives no further descriptive annex covering .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories/lighting-equipment


EUR-Lex - 52003DC0386 - EN
[2] Report on the functioning of the Medical Devices Directive 93/42/EC of 14 June 1993; Medical . [9] Decision 1786/200/EC of the European Parliament and of the Council of 23 September . Classification is based on a "classification tree" .
http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:52003DC0386:EN:HTML

ONCOLOGY/RADIOLOGY

WEEE REGULATIONS & RoHS GULATIONS Notes
. Regulations. 77. Annex B – Decision tree on scope issues . medical devices generally (Category 8 equipment) to be treated at end-of- life, but not recycled .
http://dts.valpak.co.uk/docs/weee/uk_weee_regulations.pdf


Decision tree | Enforcement | BIS
This list is taken from the WEEE Regulations. . The RoHS Directive covers both household and professional electrical and electronic equipment, so products for .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories/large-household-appliances


Washington, D.C.

THE RULES GOVERNING MEDICINAL PRODUCTS IN THE ...
Mar 18, 2011 . decision tree in Annex 1 can be used to identify whether a trial is a . object of the study is a medical device, Directive 2001/20/EC does not .
http://ec.europa.eu/health/files/eudralex/vol-10/final_03-2011.pdf

Opinion - European Commission
Jan 3, 2012 . This is the principal Medical Device Directive that sets out the conditions . of risks, nor is it intended to cover decision-making procedures regarding the . FTA (fault tree analysis), and HAZOP (hazard and operability study).
http://ec.europa.eu/health/scientific_committees/emerging/opinions/scmpmd/scmp_out25_en.htm


Los Angeles, CA

Making cellular therapies available to patients
3.3 An open door for medical device clinical trials? . Annex III: PEI decision tree for ATMP classification . . MDD: Medical Device Directive. MS: Member State .
http://www.dgra.de/studiengang/pdf/master_klumb_c.pdf

OPTHALMOLOGY

How to classify and CE mark software - Software in Medical Devices
Nov 4, 2011 . Medical devices shall have CE mark before being sold in the EU. . Looking at the EEC directive ref.1 , it is very simple to classify software: . It is very well constructed, with schema giving decision trees to follow and .
http://blog.cm-dm.com/post/2011/11/04/How-to-classify-and-CE-mark-software


Medical Device Risk Management
in regulated industries, including aviation, defense, medical devices and clinical labs. Mr. O'Leary is . to the Medical Device Directive. • Understand the . They will begin with deciding on someone to prepare the . Event Tree Analysis (ETA) .
http://www.fdanews.com/ext/files/Conference/FDAnews_PC_Medical-Device-Risk-Management-2012_JULY_brochure.pdf


Specialty: Ocular surgery

Regulations and Standards | EMDT - European Medical Device ...
European Medical Device Technology (EMDT) combines .
http://www.emdt.co.uk/categories/regulations-and-standards


Implementation of the Restriction of Hazardous Substances in - BIS
original RoHS Directive (category 8 medical devices and category 9 . An example of a 'decision tree' that could be used by economic operators to help .
http://www.bis.gov.uk/assets/biscore/business-sectors/docs/i/12-582-implementation-restriction-hazardous-substances-directive-consultation.pdf


Scientific Recommendations on the Classification of ATMPs
3.5 Decision Tree . 3. MEDICAL DEVICE. Dir. 93/42/EEC, as amended. ATMPs LEGISLATIVE . medicinal product which has the following characteristics: .
http://www.ema.europa.eu/docs/en_GB/document_library/Presentation/2009/11/WC500007627.pdf


ROHS Regulations - Government Guidance Notes - February 2011
RoHS Regulations are Medical Devices and Monitoring & Control Instruments. Please note, however, that Article 6 of the RoHS Directive places an obligation . An example of a 'decision tree' that could be used by producers to help determine .
http://www.bis.gov.uk/assets/biscore/business-sectors/docs/r/11-526-rohs-regulations-government-guidance-notes

OPTOMETRY

Exemptions | Enforcement | BIS
There are a number of material exemptions from the RoHS Directive which are . 4(1) specific to medical devices and monitoring and control instruments' and .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/rohs-exemptions


SUNFLOWER CONNECTION
Advance Medical Directives – 1/08. CPR in Adult . No Decision Tree for Abuse Reporting - 10/04. Reporting . Peripheral and Central Venous Devices - 10/06 .
http://www.aging.ks.gov/AdultCareHomes/Newsletters/Sunflower/Sunflowerconnectionindex.pdf


Reflection paper on classification of advanced therapy medicinal ...
which may fall under different legislation (e.g. medical devices, transplants and cosmetics, etc . The ATMP Regulation and the Directive 2001/83/EC Annex I Part IVii provide precise legal definitions . DECISION TREE FOR sCTMP and TEP .
http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/04/WC500126681.pdf


Multidisciplinary Evaluation for Severity of Hazards Applied to ...
The concept of risk is prominent in the European Medical Devices Directive (1): . The causal chain can be extended at the bottom of the tree, to find the technical . design decisions or by adding protection and surveillance components.
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3001776/

ORTHOPEDIC SURGERY

Regulation of health apps -A practical guide january 2012
Jan 10, 2012 . Medical Device Regulations Global Over… . Competent Authority under the MedicalDevice Directive, and provides guidance to device manufacturers. . A recent blog post10 has shed light on a decision tree thatmight be .
http://www.slideshare.net/sammielw/regulation-ofhealthappsapracticalguidejanuary2012


Title: Clinical professor of orthopedic surgery at the Medical College of Pennsylvania-Hahnemann University School of Medicine; professor of chemical engineering at Drexel University
Elkins Park, PA

Clinical Trials – application process, legislation & guidelines
Jun 19, 2012 . See decision tree in the Annex to Volume 10. Q&A document. 19/06/ . Clinical trials involving only medical devices, food supplements, or other .
http://www.imb.ie/images/uploaded/documents/The%20application%20process%20legislation%20guidelines%20and%20the%20protocol%20template%20-%20Elaine%20Breslin.pdf


Vahid Khoshnevis | LinkedIn
Public Company; 201-500 employees; BIOL; Medical Devices industry . flow charts (“Decision Tree”) and how to utilize predicate devices in 510(k) submission . requirements for class II medical devices according to Directive 93/ 42/EEC .
http://www.linkedin.com/pub/vahid-khoshnevis/a/b94/970

"Questions & Answers" Document - European Commission - Europa
Jun 1, 2010 . THE RULES GOVERNING MEDICINAL PRODUCTS IN THE . Question: The provisions of the Directive 2001/20/EC will not be . decision tree in Annex 1 can be used to identify whether a trial is a . A medical device. C.1.
http://ec.europa.eu/health/files/eudralex/vol-10/vol10_chap5_v6.pdf


The impact of structuring the interface as a decision tree in a treatment
Redelmeir, D.A., Shafir, E.: Medical decision making in situations that offer . modern interactive devices in the safety critical context of medical devices. . to Patterns) that leverages personas and patterns as primary design directives, .
http://dl.acm.org/citation.cfm?id=1783443


PRECLINICAL TESTING STRATEGIES*
Federal Institute for Drugs and Medical Devices (BfArM), Berlin, Germany. Preclinical studies . development of a testing strategy adapted to a certain medicinal product by using decision- tree . European Council Directive 75/318/ EEC of . If a “yes”/“no” decision on a justified cally justified and “indifferent” decision-tree .
http://www.diahome.org/DIAHome/resources/content.aspx?type=eopdf&file=/productfiles/8357/diaj_11724.pdf


Decision tree | Enforcement | BIS
This list of products is taken from the WEEE Regulations. The list is not exhaustive but gives examples of the type of products included in the broader category .
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories/toys-leisure-and-sports-equipment

Decision tree | Enforcement | BIS
Category 6 - Electrical and electronic tools. (with the exception of large-scale stationary industrial tools). This list of products is taken from the WEEE Regulations.
http://www.bis.gov.uk/nmo/enforcement/rohs-home/decision-tree/decision-tree-categories/electrical-and-electronic-tools


Eucomed - The Eucomed blog
Toward the best possible solution in EU medical device labelling . published “ Decision No 3”, requiring the placement on medical devices of the full postal address . of the PIP case and the Commission's plans for strengthening the medical devices directives, . Rethinking medical device manuals to save lives and trees .
http://www.eucomed.org/media-centre/blog


MDRM 2012 Agenda
. a Consequence Diagram and extend it to multiple levels to build a Decision Tree . Where to find the harmonized standards to the Medical Device Directive .
http://www.fdanews.com/MDRM2012Agenda


Lumberton, NC
Southeastern Medical Center

M. Jason Brooke | LinkedIn
Lectures on medical device product development, FDA regulation of medical . Recently published guidance and, in particular, the decision trees it contains, can . But the forthcoming recast of the medical device directives may add a few new .
http://www.linkedin.com/in/mjasonbrooke

THE RULES GOVERNING MEDICINAL PRODUCTS IN THE ...
Mar 30, 2010 . Question: The provisions of the Directive 2001/20/EC will not be implemented in . decision tree in Annex 1 can be used to identify whether a trial is a clinical trial in the sense of that . A medical device. C.1. To discover or .
http://ec.europa.eu/health/files/eudralex/vol-10/vol10_v5_en.pdf


WEEE Directive ± BMF Guidance
Categories of WEEE. 6. WEEE Decision Tree. 7. Further Information. 1. Introduction. The WEEE (Waste Electrical and Electronic Equipment) Directive is a wide.
http://www.nmma.org/assets/cabinets/Cabinet55/bmf_WEEE.pdf


Specialty: Head and neck surgery
Washington, D.C.

New Application Review Form
Nashua. NH 03063. USA. Phone : (603) 882 4412. Fax : (603) 882 1985. Medical .Devices@NSAIinc.com . For Tissue of Animal Origin falling under TSE Directive 2003/32/EC . the product. In the event of non-commercialise of the said product we commit to notify NSAI of this decision. . Product/Product Family Name: .
http://www.nsaiinc.com/services/files/RF-25-16.doc

PEDIATRICS

Pack of TEN: Best Selling Webinars by GlobalCompliancePanel
Overview: The FDA QSR and the Medical Device Directive specify certain documents or records that should . FDA's K97-1 and "Decision Tree" Model / Matrix .
https://www.globalcompliancepanel.com/control/p_product/~product_id=30126PACK


WEEE Regulations 2006 Government Guidance Notes November ...
helpful materials such as a decision tree and FAQs. This guidance . WEEE Directive requires all other medical devices (Category 8 equipment) generally to be .
http://www.bis.gov.uk/files/file54145.pdf


Decoding the regulatory maze for mobile medical application
Jun 11, 2012 . So how does a medical device OEM decode the regulatory compliance maze? . such a decision requires careful examination of every pixel and the image . EU Medical Devices Directive makes it a viable market for launching mobile . fault- tree analysis (FTA), static code analysis, system verification, and .
http://medicaldesign.com/Decoding-regulatory-maze-mobile-medical-application/


Businesses affected by the RoHS Regulations | nibusinessinfo.co.uk
A new RoHS Directive will be published in the summer of 2011. . ceramic electronic (piezoelectronic) devices; medical devices including radiotherapy equipment . Use a decision tree to determine whether equipment is covered by the RoHS .
http://www.nibusinessinfo.co.uk/bdotg/action/detail?itemId=1082901024&site=191&type=RESOURCES


Consultation on the Implementation of the Restriction of Hazardous ...
Jul 6, 2012 . (RoHS) Directive 2011/65/EU: Response Form . will be in scope, it is important that the decision tree provides accurate and clear information .
http://www.jbce.org/document_downloader.aspx?id=452

Health & Consumers DG > Press Room
SCENIHR - Minutes of the 4th Working Group on BPA in medical devices of 5 July 2012 . by Commission Decisions Commission Decision 2011/73/EU authorising the placing . 30-07-2012, food safety - Standing Committee on Fruit Plants (SCFP) . Meeting on the revision of the Tobacco products Directive with ECITA, .
http://ec.europa.eu/dgs/health_consumer/dyna/press_room/whatsnew_en.cfm


Summary of RoHS directive by RSJ Technical Consulting
On January 27, 2003, the European Parliament issued a directive “on the . Decision tree for determining whether your products fall within the scope of RoHS , . 8 & 9 equipment, i.e. medical devices and monitoring & control instruments .
http://www.rsjtechnical.com/WhatisRoHS.htm


Atlanta, GA
Specialty: Research and treatment of allergy and asthma in children

WEEE decision tree
Medical equipment tools sports equipment devices. Monitoring & conlrol Automatic instruments dispensers . @overed by scope of Directive y l'-lo Not covered .
http://www.connevans.com/ep/decisiontree.pdf

PLASTIC SURGERY

Understanding the Intricacies of Medical Device Translation | MDDI ...
Aug 1, 2006 . A translation procedure with a decision tree helps to ensure that all . manufacturers must comply with the Medical Device Directive (MDD .
http://www.mddionline.com/article/understanding-intricacies-medical-device-translation


Scoping Decision Tree - ANREEE - Associação Nacional para o ...
Accessories - Devices falling under the EEE definition and designed to . to other Community Directives, such End of Live Vehicles (ELV) Directive. . All medical products, that are direct contact with human fluids (blood, urine, sweat, etc.) .
http://www.anreee.pt/scoping_tree


Public Paper no. 59 Design of interactive medical devices - CHI+MED
the MDD (Medical Device Directive) and supported by the. MHRA, which logs adverse . of the customer and the decision trees which are rather huge.” When a .
http://dms.chi-med.ac.uk/knowledgetree/action.php?kt_path_info=ktcore.actions.document.view&fDocumentId=522


The essential list of guidances for software medical devices ...
Feb 22, 2012 . The MEDDEV 2.4.1 rev9 Classification of medical devices contains a comprehensive . about how applying the annexes II to VII of the 93/42 CE directive. . to an Existing Device contains a very done decision tree and a lot of .
http://blog.cm-dm.com/pages/The-essential-list-of-guidances-for-software-medical-devices

PSYCHIATRY

NB-MED's first reactions and comments to the
of the medical devices directives – June 27, 2008. 1. . might well become stronger with a decision tree base classification rather than the current lists, as .
http://ec.europa.eu/enterprise/newsroom/cf/_getdocument.cfm?doc_id=4904


A New Standard for Medical Device Investigations - First Clinical ...
requirements of EU Directive 93/42/EEC on medical devices (MDD) and EU Directive . Annex F (informative) – Adverse event classification decision tree .
http://firstclinical.com/journal/2011/1102_ISO_14155.pdf


New York, NY

Cepheid (112 KB) - European Commission - Europa
Unit SANCO B2, Cosmetics and Medical Devices. B-1049 Brussels . A guideline or decision tree could be used to . be covered by the IVD Directive. Cepheid .
http://ec.europa.eu/health/medical-devices/files/ivd/20_ivd_en.pdf

VOLUME 10 NOTICE TO APPLICANTS Questions & Answers
inspections of these, are provided for in the Clinical Trial Directive (Directive . The following algorithm/decision tree can be used to answer the question “Is it a clinical . medicine;. • A cosmetic productvi. • A medical device. C.1 To discover or .
http://ec.europa.eu/health/files/pharmacos/docs/doc2006/04_2006/clinical_trial_qa_april_2006_en.pdf


cok sorulanlar
Art. 4 (6) of the Biocidal Products Directive (BPD) allows, that ìMember States may . are consulted also in the decision finding process for biocidal active substances are . by the Medical Devices Directive and/or the Medical Products Directive? . Therefore, a wood preservative used in the forest on trees or on cut wood .
http://www.biyosidal.saglik.gov.tr/biocides/en_sorular.htm


Medical Devices Newsletter No. 7 - February 2004 - The Irish ...
Directive 98/79/EC became manda- tory on 7th . The Medical Devices Department of the Irish Medicines Board (IMB), over the past two years has . In brief, it means that decisions about the . Tree Analysis (FTA) or similar techniques) .
http://www.imb.ie/images/uploaded/documents/Newsletter_Issue07_February2004.pdf


European Commission Unit ENTR/F3, Cosmetics and Medical ...
Consultation on the Recast of the Medical Device Directives. . advantages, such as one integrated decision tree for risk classification. it includes four risk .
http://ec.europa.eu/health/medical-devices/files/recast_docs_2008/responses/022-r-1_en.pdf

SURGERY

Basic Principles of Risk Management for Medical Device ... - Wipro
devices are faced with the complex task of making a medical device safe for . In some cases, critical human factors and risk management decisions are made . guidance on specific risk analysis approaches and procedures such as fault tree . with the Risk Management requirements of the Medical Devices Directive .
http://www.wipro.com/Documents/resource-center/library/Whitepaper_Medical_Devices_Basic_Principles_of_Risk_Management_for_Medical_Device_Design.pdf


Washington, D.C.
Specialty: Laparoscopic surgery

International benchmark of administrative burdens related to ...
The three directives are: •. Directive 1993/42/EEC on Medical Devices (the Medical Devices di- . d. developing decision trees which should be used by all .
http://www.bertelsmann-stiftung.de/cps/rde/xbcr/SID-83785081-852B313F/bst/Ergebnisbericht_engl_Gold-Plating_060830_BST.pdf

Impact of the CE mark approval on exit opportunities and validation ...
medical device companies in making strategic decisions and for investors who . Medical Devices Directive into national law and requires CE marking. . decision trees, convince their Boards, coax their investors and incentivize their .
http://dspace.mit.edu/bitstream/handle/1721.1/65522/746798963.pdf?sequence=1


Commission Européenne
Question: A study might involve a medical device – what does this mean in . decision tree in Annex 1 can be used to identify whether a trial is a clinical trial in the . object of the study is a medical device, Directive 2001/20/EC does not apply.
http://www.ariis.fr/wp-content/uploads/2009/10/1102191.pdf


FDA raises the bar: the effects of changes in the 510(k) programme
Mar 21, 2010 . the EU's Medical Devices Directive (MDD) . tree” to determine if and when a new 510(k) . when the FDA disagrees with their decision .
http://www.newworldreg.com/pdfs/Clinica_March_2010_510(k)_changes.pdf


PRACTICE STAndARd Medication, Revised 2008
Decision Tree: Deciding About Medication Administration. 14 . administration, use medication equipment and intervene . devices and natural health products. . 21 For more information, refer to the College's Directives practice document at .
http://www.cno.org/Global/docs/prac/41007_Medication.pdf

SPORTS MEDICINE

Practice Standard: MEDICATION
Glossary and Medication Terms . . APPENDIX B: Decision Tree—Deciding About Medication Administration . . Appendix D: Medication Supply Systems . . of a drug or device pursuant to, or in anticipation of, a medication order ( NAPRA, . DIRECTIVE —a written order from an authorized prescriber for a procedure, .
http://www.nanb.nb.ca/PDF/Practice_Standard_Medication_E.pdf


OF THE RoHS DIRECTIVE
industry has developed a decision tree that identifies the various criteria for determining whether specificequipment falls under the scope of the RoHS Directive.
http://www.schneider-electric.de/documents/produkte-services/reach-rohs/rohs-fieec-en.pdf


Union, New Jersey

2nd Annual Software Design for Medical Devices Europe schedule
2nd Annual Software Design for Medical Devices Europe .
http://lanyrd.com/2012/SDMDEUROPE/schedule/

UROLOGY

The ICMJE is expanding the definition of the types of trials that must ...
outcome (for example, drugs, surgical procedures, devices, behavioral . As previously, purely observational studies (those in which the assignment of the medical intervention is not at . implement the expanded definition of clinically directive trials for all trials that . ICMJE Clinical Trial Registration Decision Tree: Step 1 .
http://research.wustl.edu/ComplianceAreas/clinical/Documents/icmje%20decision%20chart%20011409.pdf


Government Guidance notes (WEEE Regulations)
Dec 31, 2007 . A 'decision tree' which producers may find useful in determining whether . requires medical devices generally (Category 8 equipment) to be .
http://www.berr.gov.uk/files/file42909.pdf


Atlanta, GA
Atlanta Medical Center
Specialty: Urological and sexual dysfunction in women

FAQs - RS Components
How is WEEE related to the RoHS Directive? . Toys, leisure and sports equipment; Medical devices (exception of all implanted and infected products) . To view the Government decision tree which defines whether your equipment falls within .
http://uk.rs-online.com/web/generalDisplay.html?id=services/weee&file=weee_faqs

Terry Mason, M.D.

Traceability QA & RA Services - Glossary
When active in the medical devices business you might .
http://home.kpn.nl/fjmvandebergh/007.html


Chicago, Illinois

ASDA policy WEEE directive - recycling mark - Asdasupplier.com
To help to decide if a product falls within the scope of the WEEE Regulations, please use the below decision tree from the EU guidance documents: Version 2 .
http://www.asdasupplier.com/public/uploads/custom/policies/6/ASDA-POLICY-WEEE-V2-Dec-2010.pdf

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