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. However, truly collaborative supplier quality management does not have to be a zero-sum game. With a little planning and communication, you can develop mutually beneficial supplier relationships that can result in wins for both you and your suppliers. This eGuide covers the basic elements to implement a Modern Medical Device Commercialization supply chain quality strategy.
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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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5 reasons Human Factors remain important in medtech despite technological advancements like Artificial Intelligence (AI).
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Analysis of FDA draft guidance “Decentralized Clinical Trials for Drugs, Biological Products, and Devices.”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Review of April 2023 FDA draft guidance on PCCP Recommendations for AI/ML-Enabled Device Software Functions.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.
