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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Ways to safely handle Medical Device Software of Unknown Provenance and third party code in Medical Device Development.
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Using a design approach to investigate the user’s needs provides a head start on ISO 60601 Ed. 3 and IEC 62366 medical devices
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FDA 510(k) medical device submission tips and advice: being adequately prepared is essential for a smooth submission.
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FDA Wireless Guideline is a guidance document for RF wireless technology in medical devices recommending a risk-based approach.
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ISO 21500 and PMI provide guidance for Medical Device Development and Project Management Officer at StarFish Medical.
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ISO 10993-1 and Biocompatibility impact on Medical Device Plans. Financial impact of additional Medical Device testing will have a cost.
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Medical Device innovation and new product features must be balanced with an equally intense focus on Risk Analysis and Verification Testing.
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Seven tips for a smooth and successful outcome.to IEC 60601 Edition 3 submissions and electrical safety testing
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Preparation for our medical device development and contract manufacturer On-Site inspection helped our client earn a successful Factory Inspection.