Author: Jerry Sudduth, Regulatory Consultant The EU Medical Devices Regulation (MDR) Date of Application (DoA) takes effect today. Do you understand…
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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…
Author: Anne Holland, CEO and Founder As a busy medical device startup leader, you already know that you need a…
Author: Sallie McLaughlin, Principal Microbiologist Understand Impact of Changes in EO Sterilization Are you up-to-date on the current state of changes...
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Author: Anne Holland, CEO and Founder With so many critical elements involved in bringing a medical device to market, leaders...
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Author: Anne Holland, Founder and CEO Today’s medtech startups are bringing novel and innovative medical devices to market every day….
