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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2021 “most read” list: Electrical engineering and regulatory articles tie for the most popular blog topics.
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Medical Device New Product Introduction (NPI) & Commercialization lessons for medical device strategy, design, development, and NPI success.
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Pre-Testing for ISO 18562-2:2017; how to approach in-house pre-testing and add confidence to 18562:2-2017 formal testing.
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Onsite or Virtual Audits uses an internal survey of QA/RA professionals to understand and weigh the pros and cons of virtual vs onsite audits.
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2021 Update on Health Canada's medical device regulatory development during the COVID-19 pandemic and lessons learned from the experience.
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Listening Strategy for Startups offers a three-pronged approach to stay competitive within the startup ecosystem.
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Explanation of changes in medical device symbols and practical implications as a result of the ISO 15223-1:2021 Symbols Update.
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Considerations when developing a diagnostic product that is intended for use outside a traditional laboratory.
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The intent of this checklist is to aid self-assessment of your medical device commercialization readiness relating to regulatory requirements. Compare the answers you provide with stages from the StarFish Product Development Process at the end of the checklist to identify how ready you are for applicable regulatory requirements.
