Have you ever been in an FDA inspection? Are you prepared if your medical device company is inspected by the…
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Author: Amber Hilfiger, Director of Operations and Principal Quality Engineering Consultant No one wants an FDA investigator to find an…
Author: Silas Minnick, Senior Quality Engineering Consultant On September 29, 2021, the FDA issued a draft guidance regarding a new…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 When medical device companies are looking to purchase supplies or services, it’s a no-brainer…
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…
Guest Author: Ron Schmitz, President and CEO of Grand Avenue Software Are you struggling to support your evolving business needs…
Author: Anne Holland, CEO and Founder This article is the first in a series of blog posts designed to help…
