Resource Centre - StarFish Medical

Resource Centre

Discover a wealth of knowledge and insights from the experts at StarFish Medical. Our Resource Centre offers product development tips, reviews of new and cutting-edge technologies, and in-depth articles on regulatory updates and compliance in medical device development.

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How Minimum Viable Products Deliver the Most Valuable Products (MVP) for Medical Device Development
FDA Draft guidance: Marketing Submission PCCP Recommendations for AI/ML-Enabled Device Software Functions

Review of April 2023 FDA draft guidance on PCCP Recommendations for AI/ML-Enabled Device Software Functions.
FDA Action Plan for AI/ML in SaMD (Software as a Medical Device)

Overview of the FDA action plan for AI/ML in software as a medical device (SaMD) and list of best practices.
Cleanroom Validation Testing for Medical Device Manufacturing

Overview of Cleanroom Validation Testing for Medical Device Manufacturing Cleanrooms based upon actual Toronto facility experience.
Qualifying and Managing RoHS and REACH suppliers