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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A combination product is a product which comprises of two or more items which are covered by different regulations, for example a pharmaceutical and a medical device. As they are covered by two different regulatory structures, then more care needs to be taken when determining the regulatory strategy as it will be more complex.
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This blog discusses the combination product regulation basics and explains how these types of products are regulated in the US and EU.
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Director of QA/RA shares statistics on women in STEM and inspiration she has gained from inclusion improvements during her career in this article celebrating
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Overview of 2024 Regulatory trends include QMSR, LDTs, FDA guidances, and timelines in the EU for MDR and IVDR.
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How QA/RA provides value to medical device project development projects and helps support Product Development and Manufacturing teams.
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Medical device regulatory and QMS hidden costs can often be avoided when projects are well defined early to understand and know the costs up front.
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FDA cybersecurity requirements for medical devices which are considered “cyber devices”, including US government definition.
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Medical device cyber security: 2022 Update includes review of regulations and implications in an ever-evolving landscape of vulnerabilities.
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Learn about the FDA’s 2023 guidance on premarket submissions for device software functions and its impact on the medical device industry.
