Category Archives: Microbiology

New study indicates Coronavirus can linger for three days on plastic and stainless steel

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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Microbiology, Quality Systems, Safety
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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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Microbiology
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