Author: Sallie McLaughlin, Principal Microbiology Consultant Understanding and Overcoming Sterility Test Failures in Medical Device Radiation Dose Audits Paying close…
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Author: Amber Hilfiger, Director of Operations and Senior Engineering Consultant A biological evaluation report (BER) is a collective summary of…
Assessing bioburden is a critical process monitoring step in the manufacturing of sterile medical devices. A product’s natural bioburden is…
Important ST72:2019 updates can help ensure successful 510(k) submissions or avoid non-conformances The American National Standards Institute (ANSI) and the…
