Originally published in 1996, this documentation was the first template quality system for the medical device industry. Now in its fourth edition, and with over 3,000 copies sold, it has helped thousands of companies to achieve ISO 13485 registration and/or FDA compliance. It is by far the most popular and proven package on the market.

This documentation covers both ISO 13485:2016 and FDA QSR (21 CFR Part 820) requirements under one quality system, and is ideally suited for companies that must comply with both the US FDA and international regulations.

It defines a quality system that is simple, natural, and free from excessive paperwork – making it easy to operate and maintain

Extensive notes, tips, and comments are inserted directly into the template documents to help you customize the documentation for your company.


These notes

  • Identify and explain the requirements which are being addressed in the particular section of the document,
  • Alert you to sections where you may need to make changes,
  • Discuss alternative approaches and solutions that may be more suitable for particular types of companies.

It is like having a consultant by your side, anticipating your questions and helping you in real time as you customize the documentation.

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