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2011 Code of Federal Regulations Reference Guide for Medical Devices
Cambridge Healthtech Institute, April 2011
Newly Updated 2011 Edition!
The convenient and easy-to-reference pocket guide is ideal for new hire packets, giveaways, IRBs, regulatory personnel, QA/QC departments, institutions, site and management organizations, CRAs, sponsors, investigator meetings, research facilities, universities, hospitals, and more!
The CFR/ICH Reference Guide for Devices provides the critical information you need to know to stay current with the medical device and combination product industry’s codes and regulations.
The compact nature of the guide offers an easy way to keep key device regulations right at your fingertips and readily available for quick reference. Regulations included are:
- Title 21 - Food and Drugs
- Good Clinical Practice Parts 11, 50, 54, 56
- Medical Devices and Quality Systems Parts 801, 803, 806, 807, 812, 814, 820, 822
- Product Jurisdiction (Combination Products) Part 3
Plus:
- ICH Guideline
- Good Clinical Practice (E6)
- as adopted by the FDA
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