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Risk Management is an integral part of any Quality System, yet companies are struggling to keep up with regulatory updates and the impact on their QMS.
Significant changes in the regulatory climate have shifted to risk-based processes, providing a greater emphasis on the Risk Management files for medical related products.
ISO 14971:2019 was issued to harmonize those concepts across multiple regulatory bodies and incorporates some significant changes in the existing risk management landscape.
The processes described in ISO 14971 assist manufacturers of medical devices to identify the hazards associated with the medical device, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.
Join internationally esteemed regulatory experts Audrey Prosser and Rebecca Waterbury for an interactive session covering the key changes to ISO 14971 as they give you practical approaches for implementation of the new standard for both new products and legacy products.
Learn about the key updates to ISO 14971:2019 and hear insights from other companies implementing the revised standard. Explore best practices for updating risk documentation and staying compliant with international standards.