In December 2023, the U.S. Food and Drug Administration (FDA) expects to issue its long-awaited overhaul of its Quality System Regulation (QSR). The biggest change is that the new Quality Management System Regulation (QMSR) will harmonize with ISO 13485 for medical device quality management. With it comes an increased focus on risk management, with significant implications for device manufacturers.

Here we examine what ISO 13485 requires around risk management, common stumbling blocks, and how quality management system (QMS) tools can streamline compliance.

Risk in ISO 13485 vs. ISO 14971

ISO 13485 specifies requirements for implementing a QMS in medical device manufacturing. ISO 13485 makes reference to ISO 14971, which looks specifically at formal risk management processes and requirements for medical devices.

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