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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2024 FDA guidance on medical device cybersecurity covering risk management, design controls and software validation is explained in this article. Cybersecurity, Risk Management, Secure Product Development Framework (SPDF) are also covered.
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5 reasons Human Factors remain important in medtech despite technological advancements like Artificial Intelligence (AI).
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Changes in ISO 14971:2019 mean a big change to the medical device industry. The EN version was released on December 18, 2019.