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Author: Sallie McLaughlin, Principal Microbiology Consultant

Understanding and Overcoming Sterility Test Failures in Medical Device Radiation Dose Audits

Paying close attention to the Test of Sterility of the medical device for the radiation dose audits is crucial, yet incidents of dose audit failures do occur, often stemming from human error, equipment malfunction, environmental contamination, or procedural lapses. Sterilizing complex devices with diverse materials is challenging, necessitating prompt action and collaboration among experts when facing dose audit failures. In our most recent downloadable white paper, we delve into the common causes of these failures and provide practical strategies for avoiding and addressing them.

Download the dose audit failure white paper now.

Lean into our Medical Device Sterility Expertise

Effectively managing and preventing sterility test positives in radiation dose audits requires a comprehensive approach involving meticulous planning, careful execution, and swift response. It is often said that it is not ‘if but when’ a dose audit failure will happen. Be prepared for this event with procedures and strategies for managing radiation dose audit failures.

QA Consulting is the medical device consulting partner you need with the knowledge and experience to apply to your unique device. For more in-depth information and guidance on managing sterility failures, explore our detailed white paper on the topic and set up a discovery call today.