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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COVID-19 Testing Authorizations in the US and Canada

Overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada.
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Submitting a medical device application under the Health Canada Interim Order

Author describes her experience submitting a medical device application (ventilator) under the Health Canada Interim Order.
Medical Device Coverage & Reimbursement Tips and Trends

Summary of expert advice from the Medical Device Coverage & Reimbursement Conference to help guide medical device reimbursement journey.
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.
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.
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.