Quality

Compliance Standards

  • FDA CFR 21 Part 820: Quality System Regulation - Medical Devices
  • FDA Guidance Document: Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing General Program Memorandum – G95-1
  • ISO 13485: 2003 Medical Devices - Quality management systems — Requirements for Regulatory Purposes
  • ISO 14971: 2009 Medical Devices - Application of Risk Management to Medical Devices
  • EN 980: 2008 Symbols for use in the labeling of medical devices
  • ISO 11135-1: 2007 Sterilization of health care products -- Ethylene oxide
  • EN ISO 11607-1: 2009 Packaging for terminally sterilized medical devices
  • ISO 10993-1: 2009 Biological Evaluation of Medical Devices
  • ASTM D4169-09: Standard Practice for Performance Testing of Shipping Containers and Systems
  • ASTM F1980-07: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices