Author: Amber Hilfiger, Director of Operations and Senior Engineering Consultant A biological evaluation report (BER) is a collective summary of…
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The QA Consulting Team enjoyed a little online celebration to celebrate 20 years of success with a virtual toast from…
(How I learned to love quality and you can too!) Author: Anne Holland, CEO and Founder It’s hard to believe…
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…
Author: Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant As the global demand for medical devices grows in…
What’s New in ISO 14971:2019 and ISO/TR 24971:2020 Author: Silas Minnick, Senior Quality Engineering Consultant What’s in your ISO 14971…
Author: Laura Lakemeyer, Senior Microbiology and Quality Consultant Assessing bioburden is a critical process monitoring step in the manufacturing of…
Author: Anne Holland, CEO and Founder You know the drill. You’re tasked with identifying and selecting a medical device quality…
