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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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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Overview of Cleanroom Validation Testing for Medical Device Manufacturing Cleanrooms based upon actual Toronto facility experience.
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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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FDA Approved or Cleared Medical Device – the pathway you choose depends on the level of risk it represents and its intended use.
