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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 .

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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.

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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) .

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 .

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 .

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 .

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) .

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 .


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 .

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 .

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 .

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 .


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 .

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.

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 .

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 .

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].

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.


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 .

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 .

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.

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 .

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 .

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 .

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 .

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 .


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) .

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 .

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.

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.

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 .

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.

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 .


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 .

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 .

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.

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 .

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.

New Haven, CT
Specialty: Reproductive endocrinology

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) .


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 .

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 .

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 .

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 .

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 .

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 .

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 .


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 .

DIRECTIVE 98/8/EC CONCERNING THE PLACING ON . used in In Vitro Diagnostic Medical. Devices .............................................................................. 22 .

Methodist Hospital
Houston, Texas

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: .

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 .

MedPass International Careers
. Development, Regulatory Strategies and EU Market Access for Medical Devices. . MEDPASS INTERNATIONAL MEDICAL DEVICE CRO - All rights reserved .

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.


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 .

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 .

Atlanta, GA
Grady Hospital

B Decision tree to assist interpretation of the scope of the Directive . Council Directive on Waste Electrical and Electronic Equipment . 8) Medical devices .

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.

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 .

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 .

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 .


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).

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 .

New York, NY

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) .

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).

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 .

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 .


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 .

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 .

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 .

Feature Article | EMDT - European Medical Device Technology
European Medical Device Technology (EMDT) combines .

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) .

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 .


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 .

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 .

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, .

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 .

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 .

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 .

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" .


. 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 .

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 .

Washington, D.C.

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 .

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).

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 .


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 .

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) .

Specialty: Ocular surgery

Regulations and Standards | EMDT - European Medical Device ...
European Medical Device Technology (EMDT) combines .

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 .

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: .

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 .


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 .

Advance Medical Directives – 1/08. CPR in Adult . No Decision Tree for Abuse Reporting - 10/04. Reporting . Peripheral and Central Venous Devices - 10/06 .

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 .

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.


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 .

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 .

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 .

"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.

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, .

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 .

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 .

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.

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 .

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 .

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 .

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 .

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.

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: .


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 .

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 .

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 .

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 .

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 .

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, .

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 .

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 .


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 .

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.) .

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 .

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 .


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 .

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 .

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 .

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 .

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 .

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) .

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 .


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 .

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 .

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 .

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.

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 .

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 .


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, .

industry has developed a decision tree that identifies the various criteria for determining whether specificequipment falls under the scope of the RoHS Directive.

Union, New Jersey

2nd Annual Software Design for Medical Devices Europe schedule
2nd Annual Software Design for Medical Devices Europe .


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 .

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 .

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 .

Terry Mason, M.D.

Traceability QA & RA Services - Glossary
When active in the medical devices business you might .

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 .



Content Last Modified: 2/6/2006 3:04:00 PM
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