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.

Keyword search

Service

Sector

Expertise

Topic

Author

Which standards apply to your medical device?

Knowing which medical device standards apply to your device is an essential part of successfully bring a medical device to market.
Where do you find inspiration for work?

Inspiration for work from engineers, regulatory, quality, design, and program management creative professionals in medical device development.
Health Canada improvements: Getting new devices to market

Health Canada improvements: Getting new devices to market, strengthen monitoring and follow-up and provide more information to Canadians.
How Regulators are addressing COVID-19 related Medical Device approvals

Round-up of how Regulators in the US, Europe, and Canada are addressing COVID-19 related Medical Device approvals by QA/RA specialist.
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.
Why an electrical isolation diagram improves your medical device design

Creating an electrical insulation diagram early on helps to choose the right parts and is required by IEC 60601-01.