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Webinar 5: Getting ready for QMSR

In the first of a series of webinars on this topic, we review additional risk-based requirements for a QMS under the upcoming Quality Management System Regulation (QMSR).

In February 2022, the FDA proposed an amendment to the current Quality System Regulation (QSR) for medical devices to align it more closely with the international consensus standard ISO 13485:20161. The amended regulation, when approved, will be referred to as the Quality Management System Regulation (QMSR) to better reflect the emphasis on the managemen…

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Let's Talk Risk!
Let's Talk Risk! with Dr. Naveen Agarwal
Every Friday, Dr. Naveen Agarwal leads a Let's Talk Risk! conversation with industry colleagues to discuss practical challenges and share best practices in risk management. In the highly regulated world of medical devices, most practitioners struggle with the "how" of risk management. Regulatory requirements are complex, confusing and ever changing. Establishing an effective risk management process that satisfies the scrutiny of regulators and auditors without creating barriers to innovation is a significant challenge in the industry. Dr. Agarwal believes that no single "expert" has all the answers, and it is only when we connect, share and learn from each other that we all become better. Let us keep learning together!