This risk management procedure pertains to the entire product realization process, and the procedure is compliant with ISO 14971:2019 and the EU MDR.
The purpose of this 9-page procedure is to define requirements for risk management. The procedure was recently updated to reflect the changes in the ISO 14971, 3rd edition (ISO 14971:2019), the EU MDR, and we have incorporated references to our new Usability Procedure (SYS-048).
This risk management procedure pertains to the entire product realization process from the beginning of design and development through obsolescence. The procedure is compliant with new EU MDR and EN ISO 14971:2012–including the seven deviations identified in Annex ZA, ZB and ZC. These requirements are more stringent than ISO 14971:2019, but it is a deviation from the international standard recognized by the US FDA and Health Canada. This procedure is the primary document meeting the applicable regulatory requirements for risk management as defined in [Company Name]’s Quality System Manual (POL-001). The procedure has also been updated to address the updated risk management requirements in Annex I (1-9) of Regulation (EU) 2017/745 (i.e., the EU MDR). This procedure applies to medical devices distributed in the United States, Canada and the European Union.
Design & Risk Management Plan
At the beginning of each design project a design plan is created. The design plan should include a risk management plan section or a separate risk management plan shall be created. The risk management plan only needs to cover from the beginning of the project to product release–not post-market risk activities. The risk management plan during the design phase shall include at least the following elements:
- hazard identification
- risk assessment
- risk control option analysis
- risk control verification of effectiveness
- risk / benefit analysis for each individual risk and the overall residual risks of the device
- process failure modes and effects analysis
- a risk management report summarizing the results of risk management activities
Annex F of the ISO 14971:2007 standard provides a template that may be used for a risk management plan, and the ISO/TR 24971:2020 guidance is expected to provide similar content once it is released.
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SYS-010, Risk Management Procedure – compliant with EN ISO 14971:2012. Includes templates for documentation of design risk management and process risk management. This procedure has been updated for compliance with ISO/DIS 14971:2018 and Regulation (EU) 2017/745.
Implementing a Risk Management Process Compliant with ISO 14971:2007. This webinar recording also explains how to address the seven deviations identified in EN ISO 14971:2012.
This is a 10 question quiz with multiple choice and fill in the blank questions. The completed quiz is to be submitted by email to Rob Packard as an MS Word document. Rob will provide a corrected exam with explanations for incorrect answers and a training effectiveness certificate for grades of 70% or higher.
If you are interested in risk management training, we also have a risk management training webinar that was updated in 2018 for the new draft 3rd edition of ISO 14971. Now that ISO 14971:2019 has been released, we have confirmed that both the training webinar and this procedure are compliant with the 3rd edition.
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