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 look at some of the differences between FDA and EU MDR process and requirements for clinical investigations.
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In today’s increasingly complex supply chain sourcing environment, it is common for companies to treat their supplier relationships as opportunities for consistent cost savings.
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Qualifying for FDA Medical Device Development Tools (MDDT) program, categories, history, benefits, CDRH Qualification and Decision Framework.
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5 FDA Inspection tips from our QA/RA experts help make FDA inspections efficient, effective and successful.
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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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Analysis of FDA draft guidance "Decentralized Clinical Trials for Drugs, Biological Products, and Devices."
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Review of April 2023 FDA draft guidance on PCCP Recommendations for AI/ML-Enabled Device Software Functions.
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Strategies to maximize outcomes for interactions during regulatory pre-submission meetings using 4 simple, but effective steps.
