Author: Sallie McLaughlin, Senior Microbiology Consultant EN 17141:2020 Cleanrooms and associated controlled environments – Biocontamination control, introduced in August of…
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Author: Sallie McLaughlin, Senior Microbiology Consultant If the sterilization of medical devices falls within your roles and responsibilities, it is…
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…
The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part…
