MD.definition.lifecycle.supplementary.materials.pdf

Medical Devices: Definition and Lifecycle
SupplementaryMaterials
Table of Contents
Tips and Best Practices ............................................................................................................................. 1
Acronyms Guide ....................................................................................................................................... 2
References and Resources ........................................................................................................................ 3
Course Storyboard.................................................................................................................................... 4

RAPS Online University | Medical Device: Definition and Lifecycle 1
TIPS AND BEST PRACTICES
SYSTEM REQUIREMENTS
o Google Chrome is the preferred browser; participants can also use a current version of Firefox, Safari or Microsoft Edge.
o Participants will need to disable their browser’s pop-up blocker for some functions to work
USING ONLINE UNIVERSITY
There are instructional videos accessible from the learning portal Home page covering the features and functions of the course players and online
system to help maximize and simplify your learning experience.
MAXIMIZE YOUR LEARNING
Courses are organized into lessons to let you to fit in learning as your schedule permits. For optimal comprehension and retention, however, try to
complete at least 15–30 minutes of content at a time. Lesson title pages offer a convenient point to put down the course and the bookmarking feature
automatically saves your progress.
To ensure bookmarks save properly, exit the course player via the X at the top-right, confirm, and then let the window close by itself.
It is also helpful to have this packet of supplementary materials handy when going through the content. The course Storyboard is intended to be an
organizational tool for your own notetaking and not the full course text; printable full text is not available. Some of the Storyboard images may appear
blank or incomplete because the multimedia used cannot be exported to other formats.
TAKING THE FINAL ASSESSMENT
• 30 questions— a mix of true/false, multiple choice and/or numeric test items
• 80% passing score
• Untimed completion
• An answer key is not provided
• Cannot “save and return”
• No limit on the number of attempts allowed
• Each time the assessment is taken some of the questions will change

Acronyms Guide
510(k) Premarket Notification
AHWP Asian Harmonization Working Party
AIMDD Active Implantable Medical Device Directive
CA Competent Authority
CAPA Corrective and Preventive Action
CAT Computed Axial Tomography
CDRH Center for Devices and Radiological Health
CE Conformité Européenne, European Conformity
CETF Clinical Evaluation Task Force
CFR Code of Federal Regulations
D&D Design and development
DHF Design History File
DMR Device Master Record
DSMICA Division of Small Manufacturers, International and
Consumer Assistance
EC European Community
ER Essential Requirement
EU MDR European Union Medical Device Regulation
FDA U.S. Food and Drug Administration
FDAMA FDA Modernization Act
FD&C Act Food, Drug and Cosmetic Act
FMEA Failure Mode-and-Effects Analysis
GHTF Global Harmonization Task Force
GMP Good Manufacturing Practice
IMDRF International Medical Device Regulators Forum
IV intravenous
IVD In vitro diagnostic
IVDD in vitro diagnostic medical devices
MDD Medical Device Directive
MDUFMA
Medical Device User Fee and
Modernization Act
NB Notified Bodies
OCP Office of Combination Products
PMA premarket approval
QMS Quality Management System
QSR Quality System Regulation

REFERENCES ANDRESOURCES
• 21 CFR 803, Medical Device Reporting
• 21 CFR 806, Reports of Corrections and Removals
• 21 CFR 807, Premarket Notification (510k)
• 21 CFR 814, Premarket Approval of Medical Devices
• 21 CFR 820, Quality System Regulation
• Council Directive 93/42/EEC of 14 June 1993 concerning medical devices (MDD) (as amended through 2007/47/EC)
• Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable
medical devices (AIMDD) (as amended through 2007/47/EC)
• Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (IVDD) (as
amended through 596/2009/EC)
• Federal Food Drug and Cosmetic Act (FD&C Act) (21 USC)
• ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing
• ISO 14971:2007, Medical devices — Application of risk management to medical devices
• ISO 13485: 2003, Medical devices — Quality management systems — Requirements for regulatory purposes
• Medical Devices Expert Group, Report on the Functioning of the Medical Devices Directive (93/42/EEC of 14 June 1993) (5 June 2002)
• Personal correspondence with Dr. Ralph Jackson, Curator of Romano-British Collections, Head of Roman Britain & Britain and
Medieval Europe Department of Prehistory and Europe, British Museum (22 January 2007)
• Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices Version 1.10, August 2011 —
(European Commission)
• Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive
2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and
93/42/EEC
• Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and
repealing Directive 98/79/EC and Commission Decision 2010/227/EU

COURSE STORYBOARD

Notes:
Notes:

MD.definition.lifecycle.supplementary.materials.pdf

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