About: Casey Frushour

Recent Posts by Casey Frushour

Tips for Surviving a Virtual Audit

Tips for Surviving a Virtual Audit
In the Coronavirus Era You May Experience Your First-ever Remote Audit Author: Amber Hilfiger, Director of Operations and Senior Quality Engineering Consultant Audits are unavoidable in the medical device industry. Even a global pandemic can’t stop them. While COVID-19 may have grounded planes, audits that provide the necessary checks and balances on quality systems, confirm…
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Audits, Quality Systems, Regulatory Affairs
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Get your Sterile Device to Market with Ease: Understanding Five Key Endotoxin Testing Requirements

Get your Sterile Device to Market with Ease: Understanding Five Key Endotoxin Testing Requirements
By: Laura Lakemeyer, Senior Microbiology and Quality Consultant Important ST72:2019 updates can help ensure successful 510(k) submissions or avoid non-conformances The American National Standards Institute (ANSI) and the Advancement of Medical Instrumentation (AAMI) recently released substantial revisions to the updated standard ANSI/AAMI ST72:2019, Bacterial endotoxins – Test methods, routine monitoring, and alternatives to batch testing.…
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Microbiology, Regulatory Affairs
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