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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FDA Guidance on Non-Clinical Bench Performance Testing Information

FDA provides a roadmap to follow for premarket submission in their guidance on Content and Format of Non-Clinical Bench Performance Testing.
Big changes in ISO 14971:2019

Changes in ISO 14971:2019 mean a big change to the medical device industry. The EN version was released on December 18, 2019.
510(k) submission: 9 Tips for success

9 tips for 510(k) submission along with lessons learned from a recent successful experience submitting a medical device to the FDA.

Resource Centre

FDA Guidance on Non-Clinical Bench Performance Testing Information

Big changes in ISO 14971:2019

510(k) submission: 9 Tips for success