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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What is a combination product and why is this important from a regulatory perspective? The simple answer is that 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.
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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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On November 4th, 2021, the FDA issued a new draft guidance: Content of Premarket Submissions for Device Software Functions. This draft guidance was issued for commenting and is intended to replace their previous guidance on the subject, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices from May 2005.