Do you know how to handle complaints regarding your medical device? Medical device companies that market their devices in Europe…
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Guest Author: Tasha Bond, Founder of Ikigai Medical Development and COO of Sana Health, Inc. Many medical device manufacturers relegate…
Author: Amber Hilfiger, Director of Operations and Sr. Consultant If your biological evaluation report is dated 04/11/21, on what date…
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…
Guest Author: Ron Schmitz, President and CEO of Grand Avenue Software Are you struggling to support your evolving business needs…
