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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Tips and a quiz for picking and approving calibration equipment vendors for medical device verification and validation.
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Advice to help companies determine when to start thinking about setting up a Startup Quality Management System.
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The book Bad Blood eloquently demonstrates the importance of properly developing medical devices under ISO 13485.
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ISO/IEC 17025:2017 includes many changes. Three points to keep in mind: more options, involvement of risk, updates in current technology.
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Why design control is required for medical devices and is superfluous in the consumer goods design with advantages and disadvantages.
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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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Two ISO 13485:2016 section 7 changes impact your Quality Management System (QMS) are taking a risk based approach and documenting everything.
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Tips to manage competence and training, keep up to date and ensure personnel are trained and competent to perform their duties.
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Highlights of lessons learned from 3 FDA inspection strategies and visits to medical device manufacturer and clients.
