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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Design control shouldn’t inhibit creativity; it should enable it by providing a safety net in the form of a system to fall back on.
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Exploration of applying IEC-62366-1:2015 or human factors engineering to the design of medical devices compared to the FDA guidance document.
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Data de-identification should be the first option to consider when dealing with Personal Health Information (PHI) security.
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Medical device labeling includes all information provided with the device. Article identifies jurisdictions and associated “do’s and don’ts”.
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Health Canada has announced online publication of Regulatory Decision Summaries (RDS) and a list of decisions under review.
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The importance of medical device performance specifications and effectiveness goals are often overlooked in the design process.
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Regulatory affairs expert explains how to write a best practice ISO 9000 Medical Device Quality Manual using 3 simple rules.
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Quality managers don’t have a magic wand to turn a bad product into a good one. Quality management needs an objective definition for quality.
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Design control shouldn’t inhibit creativity; it should enable it by providing a safety net when the unknowns start showing up during design.