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ISO 13485 Consultants Guide Regulatory Compliance

The development, manufacturing, marketing and sale of medical devices is highly regulated. This can be a complex area. Fortunately, as ISO 13485 consultants we’ve been there many times before and can support you. We can help you successfully navigate regulatory hurdles and comply with the standards that apply in your markets.

Beginning with a quality and regulatory/clinical path strategy, we ensure that your product meets ISO 13485 design control and documentation standards and FDA specifications for medical device clinical trials. We will work with you or your consultants to help with full regulatory clearance.

StarFish also provides support for regulatory applications. From investigational testing to device license applications, we can help make your device market ready.


Regulatory Checklist

Services include:

  • define regulatory pathway in the jurisdictions of interest
  • regulatory strategy
  • create and run verification testing protocols
  • manage electrical safety certifications (e.g. IEC 60601)
  • investigational testing and device license applications
  • product validation
  • clinical trials
  • technical file and regulatory submissions
  • support review


I commend you for your vision in looking well ahead to regulatory and contract assembly issues, as well as a decision to concurrently develop key prototypes. This ultimately led to a successful design concept. All initial design requirements were satisfied.

Ian Maclean
Project Manager
Koven Technology Canada Inc.

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