Author: Anne Holland, CEO and Founder When medical device companies are looking to purchase supplies or services, it’s a no-brainer…
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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: 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…