Regulatory Support

Ensure Regulatory Compliance

The development, manufacturing, marketing and sale of medical devices is highly regulated. This can be a complex area. Fortunately, 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.

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

StarFish can also provide support for regulatory applications starting from investigational testing and device license applications to implementing our “QMS-in-a-Box” solution for getting your device market ready.

Services include:

  • defining your regulatory pathway in the jurisdictions of interest
  • helping you with regulatory strategy
  • supporting investigational testing and device license applications
  • creating and running all verification testing protocols
  • supporting you through product validation
  • supporting your clinical trials
  • managing all electrical safety certifications (e.g. IEC 60601)
  • preparing your technical file and regulatory submissions
  • supporting you through the review processes
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.