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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Writing and implementing standard operating procedures (SOPs) for the manufacture of medical devices is required by ISO 13485, FDA, and other regulatory bodies. An SOP is a set of written instructions that documents a routine or repetitive activity that is followed by employees in an organization. The development and use of SOPs are integral parts of a successful quality system. They provide directions to perform a job properly and consistently to achieve predetermined specifications and quality end results. SOPs address all requirements to complete the job or process safely and effectively.
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Considerations for selecting medical device camera image sensors including CCD vs. CMOS and monochromatic vs. color varieties.
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Examples of how to apply tolerance studies that add value to medical device design and ultimately to biomedical start-ups.
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How to identify hidden costs in medical device Verification & Validation along with mitigation measures to reduce the expense.
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Exploration of the potential in using Medical Device AI with tips on how to avoid pitfalls in AI implementation.
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Review of the FDA transition plan for medical devices currently marketed under Emergency Use Authorizations with implications for devices.
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How the FDA Catalog of Regulatory Science Tools can reduce risk in medical devices and explores several tools and categories.
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Medical Device New Product Introduction (NPI) & Commercialization lessons for medical device strategy, design, development, and NPI success.
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Outlines how medical device designers can perform in-house Medical Device Drop Test per IEC 60601-1 before third party testing.
