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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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.
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Medical device artificial intelligence (AI) overview of AI, applications and devices, investment landscape, and regulatory implications.
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2020 Medical device development videos include COVID implications for research and POC devices, optimizing founder value, manufacturing for NPI, IVD insights.
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COVID-19 Ventilator Design team discuss their top insights and lessons learned from the time constrained, critical ventilator project.
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How FDA Breakthrough Devices Program provides advantages for novel devices and can significantly reduce a product’s time to market.
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Overview of COVID-19 testing authorizations and developments of the COVID-19 pandemic in the United States and Canada.
