Author: Amber Hilfiger, Director of Operations and Principal Quality Engineering Consultant No one wants an FDA investigator to find an…
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Author: Silas Minnick, Senior Quality Engineering Consultant On September 29, 2021, the FDA issued a draft guidance regarding a new…
Author: Anne Holland, CEO and Founder Verification and validation are crucial aspects of a medical device’s development. They work together…
Author: Sallie McLaughlin, Senior Microbiology Consultant EN 17141:2020 Cleanrooms and associated controlled environments – Biocontamination control, introduced in August of…
Author: Anne Holland, CEO and Founder When medical device companies are looking to purchase supplies or services, it’s a no-brainer…
Author: Silas Minnick, Senior Quality Engineering Consultant With the release of ISO 14971:2019 and ISO/TR 24971:2020, medical device manufacturers are…
Challenge: Eximis Surgical sought assistance in taking their startup from the early stages as an R&D company to implementing an…
Guest Author: Tasha Bond, Founder of Ikigai Medical Development and COO of Sana Health, Inc. Many medical device manufacturers relegate…
Company objectives: Stiel Tech was seeking to commercialize a wound irrigation system to treat hard-to-heal wounds. Solution: Using good manufacturing…
Author: Amber Hilfiger, Principal Consultant Navigate FDA Good Documentation Practices and Master the Art of Paper Trails Picture this: you're...
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