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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Enjoy our 2017 Readers’ Choice Blogs and StarFish Medical articles, images, events and videos from our monthly newsletter.
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StarFish Medical videos help viewers learn medical device design, development and manufacture insights and tips from the people at StarFish.
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RoHS and REACH are two regulations that requires compliance if a company intends to sell in the European Union.
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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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How to handle recent medical product development regulatory changes under the 21st Century Cures Act and device exemption list.
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Start early to avoid surprises when preparing for MDR 2017/745. The new EU medical device regulations will come into full force in Q2 2020.
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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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MDSAP Medical Device Single Audit Program audits will help ensure compliance with QMS and reduce the audit/inspection burden.
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Comparison of the biggest unknown between IEC 62366:2007 and IEC 62366 -1:2015– Fig. 5.10 User Interface of Unknown Provenance (UOUP).
