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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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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Outlines how medical device designers can perform in-house Medical Device Drop Test per IEC 60601-1 before third party testing.
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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.
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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.
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RoHS 3 (EU 2015/863) expands the list of prohibited substances from 6 to 10 adding 4 phthalates. Learn if your device is RoHS 3 compliant.
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FDA ASCA Pilot Program is expected to bring medical devices to patients and users more efficiently by using ASCA-accredited labs.
