Category Archives: Microbiology

Bioburden Basics for Sterile Medical Devices

Author: Laura Lakemeyer, Senior Microbiology and Quality Consultant Assessing bioburden is a critical process monitoring step in the manufacturing of sterile medical devices. A product’s natural bioburden is an estimation of the microbiological contamination level of the device and is usually measured once manufacturing has been complete, but, prior to the sterilization process. Failure to…
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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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New study indicates Coronavirus can linger for three days on plastic and stainless steel

What should we do if a returned product comes back  potentially contaminated? What if an employee tests positive for COVID-19? In the wake of the coronavirus pandemic, clients have been contacting QA Consulting over the past few weeks with important questions. If your company receives a medical device shipment back from a customer such as…
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Dissecting the FDA’s Expectations for Biocompatibility of Medical Devices: Five Key Considerations

The FDA issued a long-awaited final guidance Use of International Standard ISO 10993-1, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process replacing the historical "Blue Book Memorandum #G95-1" (1995). The new guidance, released in June, is a substantial upgrade from its predecessor and serves the purpose of guiding…
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