![]() And, in early 2022, the FDA proposed an amendment to the QSR that will incorporate ISO 13485. Yet, the significance of ISO 13485 certification becomes more apparent given that compliance with that standard can serve as evidence of a compliant QMS during FDA audits. In fact, medical devices are considered “adulterated” if the associated quality management system (QMS) is not compliant with the QSR. The QSR is the regulation that ensures all medical devices created and developed within the United States are safe and follow satisfactory quality processes throughout their development.Ĭurrently, compliance with ISO 13485 is voluntary, while compliance with the QSR is not. Against that background, the next step is to understand the base requirements of the ISO 13485 standard and its relationship to 21 CFR Part 820, the Quality System Regulation (QSR), which codifies the expectations and requirements of the FDA. ISO 13485 is one of many International Organization for Standardization (ISO) standards, and it is specific to the expectations and requirements for a compliant medical device quality management system in the medical device industry. But there are ways to prepare for and conduct an audit that will keep you out from under the desk and produce positive results. Indeed, the variety of quality and safety standards and requirements medical device manufacturers must adhere to can be overwhelming, especially if operations are international as well as domestic. Whether it’s a high-speed tennis ball or an audit, keeping your eye on the target at all times is the key to success.Įven the mention of the term “audit” can send people cowering under their desks. We all know a moving target is hardest to hit. If you would like further information on our wide range of templates or have any suggestions for improvements that require support in addition to our templates in the form of other Medical Device Quality Assurance or Regulatory Affairs services, contact us at.
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