Challenge: Eximis Surgical sought assistance in taking their startup from the early stages as an R&D company to implementing an…
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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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Author: Jerry Sudduth, Regulatory Consultant The EU Medical Devices Regulation (MDR) Date of Application (DoA) takes effect today. Do you understand…
Guest Author: Ali Gallagher, J.D. Non-compliance with FDA regulations can not only delay your product getting in the hands of…
By QA Consulting, Inc. With the rising demand for connected medical devices, understanding your products’ potential vulnerabilities and the evolving…
Author: Anne Holland, CEO and Founder A medical device gap analysis evaluates your current Quality Management System (QMS) compared to…
Author: Anne Holland, CEO and Founder A few weeks ago, I moderated a panel discussion for the Texas Medical Device…
Guest Contributor: Richard Dolman, Certified Enterprise Coach, Agile Velocity Contrary to popular belief, Agile isn’t the Wild Wild West. Adopting…
