(How I learned to love quality and you can too!) Author: Anne Holland, CEO and Founder It’s hard to believe…
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(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…
Assessing bioburden is a critical process monitoring step in the manufacturing of sterile medical devices. A product’s natural bioburden is…
Author: Anne Holland, CEO and Founder You know the drill. You’re tasked with identifying and selecting a medical device quality…
FDA RESPONSIVE TO THE PUBLIC HEALTH RISK ASSOCIATED WITH COVID-19 Author: Anne Holland, CEO and Founder One does not generally…
In the Coronavirus Era You May Experience Your First-ever Remote Audit Author: Amber Hilfiger, Director of Operations and Senior Quality…
Important ST72:2019 updates can help ensure successful 510(k) submissions or avoid non-conformances The American National Standards Institute (ANSI) and the…