Transitioning to ISO 13485:2016

Now is the time to get the 13485 monkey off your back.

  • Starting from scratch? I have cracked the 13485:2016 nut, and can provide a full deck of documents tailored to your needs.
  • Looking to update your current system? I have developed some tools for gap analysis so you can self-diagnose your needs.
  • Need training? I can provide a “live” training session via webinar or in your office if you are in the SF Bay area.

Want to discuss? Please directly book a call time by clicking here.