In the Pockets of Millions of Industry Professionals - Your Company can be too! Find out more - sales@gmppublications.com

GMP Publications - Code of Federal Regulation Handbooks by the FDA

US, EU and Canadian Medical Device Combination

US.EU.CanadaMedicalDeviceCombination
978-1-935131-28-1

US FDA Title 21 CFR Parts

Part 11 - Electronic Records/Electronic Signatures (ERES)
Part 50 - Protection of Human Subjects
Part 54 - Financial Disclosure by Clinical Invest.
Part 56 - Institutional Review Boards
Part 801 - Labeling Medical Devices
Part 803 - Medical Device Reporting
Part 806 - Medical Devices; Reports of Corrections & Removals
Part 807 - Establishemnt Registration and Device Listing for Manufacturers & Initial Importers of Devices
Part 812 - Investigational Device Excemptions
Part 814 - Premarket Approval of Medical Devices
Part 820 - Quality Systems Regulations
PMA & 510k Guidance Document,

Canadian Medical Device Regulations - Last Amended on February 22, 2023

EU 2017/745 Medical Device Regulation

US FDA Inspection of Medical Device Manufacturers 7382.845











Quantity   1 - 99     100 - 249     250 - 499     500 - 999     1000+  
Price $30.95 $24.95 $19.70 $15.90 $12.90

Quantity   


example: 211, ISBN, Drug, GMP, Etc. - Press Enter
Mix and Match Interphex 2024 Sterile GMP End of Year Special New Books GMP GCP-DRUG Featured Publication Featured Publication
  • Guaranteed Lowest Price
  • Quantity Discounts Available
  • Always Current, Up-To-Date
  • Company Logos Available
  • Special Customizations
  • Pocket-sized 3.75" x 6.25"
  • Prep for FDA & Client Audits
  • Employee Training & Reference
  • Promotional "giveaways"
  • Tradeshows and meetings

Our Valued Clients










Return to the GMP Publications home page View your shopping cart-->