CDRH GMP Guidelines

Print this page         
  1. Design Control Guidance For Medical Device Manufacturers (March 1997)
  2. Do It By Design: An Introduction To Human Factors in Medical Devices (December 1996)
  3. General Principles of Software Validation (January 2002)
  4. Guide to Inspections of Foreign Medical Device Manufacturers(September 1995)
  5. Human Factors Implications of the New GMP Rule (April 1998)
  6. Medical Device Quality Systems Manual
Last Update: 28 September 2011

My ISPE

  • Click to go to My Communities of Practice
  • Click to go to My Affiliate or Chapter
  • Click to go to My Profile
Click to go to the Member Gift