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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Understanding similarities and differences between Medical Device 510(k) and CE Marking regulatory pathways helps harmonize overall regulatory strategy.
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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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Review of sections 4, 5 and 6 of ISO 13485:2016 and the major changes from the 2003 version with potential impacts on QMS.