Author: Amber Hilfiger, Director of Operations and Senior Engineering Consultant A biological evaluation report (BER) is a collective summary of…
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Author: Laura Lakemeyer, Senior Microbiology and Quality Consultant Assessing bioburden is a critical process monitoring step in the manufacturing of…
By: Laura Lakemeyer, Senior Microbiology and Quality Consultant Important ST72:2019 updates can help ensure successful 510(k) submissions or avoid non-conformances…
What should we do if a returned product comes back potentially contaminated? What if an employee tests positive for COVID-19?…
The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part…
