Author: Sallie McLaughlin, Senior Microbiology Consultant EN 17141:2020 Cleanrooms and associated controlled environments – Biocontamination control, introduced in August 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 few weeks ago, I moderated a panel discussion for the Texas Medical Device…
Author: Amber Hilfiger, Director of Operations and Senior Engineering Consultant A biological evaluation report (BER) is a collective summary of…
Author: Anne Holland, CEO and Founder CEOs can be demanding, I should know. Often, instead of working alongside their quality…
Author: Anne Holland, CEO and Founder This article is the first in a series of blog posts designed to help…