Camensys - FDA Readiness Assessment

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Camensys - FDA Readiness Assessment
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FDA Readiness Assessment
All medical device manufacturers need to
implement a quality system as per ISO 134852016
whether they are manufacturing a rubber tube,
hospital bed, catheter, artificial heart or a
software.
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• Though FDA regulation 21 CFR Part 820 differs
  from ISO 134852016 in some areas, it is
  advisable to follow ISO 13485 for three major
  reasons
• ISO 134852016 is more robust and complete than
  21 CFR Part 820. It has a stronger tie to risk
  management principles and ISO 14971.
• ISO 134852016 is a global standard which means
  if you are compliant to this standard, you are
  ready for most other countries including Canada,
  European Union, Japan etc.
• More importantly FDA is planning to adapt ISO
  13485 for the quality management of medical
  devices. They are planning to announce this in
  the fall of 2019.

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• If your medical device software uses Machine
  Learning and other advanced AI methodology, there
  are some additional requirements for getting FDA
  approval. The questionnaire includes those
  requirements based on FDAs early thoughts on
  this subject.
• It might look a little intimidating, just like
  any other regulatory requirements look like, but
  there are ways to make your life much easier to
  implement these at a least cost and least
  overhead.

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Thank You
https//www.camensys.com/fda-readiness-assessment