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, but this was not carried over to the ISO/TR 24971:2020 guidance. The new guidance provides a detailed explanation of the requirements for a risk management plan in section 4.4 instead.
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SYS-010, Risk Management Procedure – compliant with EN ISO 14971:2019. Includes templates for documentation of design risk management and process risk management. This procedure has been updated for compliance with ISO 14971:2019, ISO/TR 24971:2020, and Regulation (EU) 2017/745.
The topic of the month of April is risk management (SYS-010 is discounted 50% from March 21, 2022 to April 20, 2022 if you use the “ISO 14971” discount code). If you are interested in risk management training, our risk management training webinar is being updated for the second time. The previous update was in October of 2018. The new two-part webinar will be hosted on March 29, 2022 and April 5, 2022. Part 1 will cover Clause 1 through Clause 7.1, while Part 2 will cover Clause 7.2 through Clause 10. We have selected Clause 7.2 to begin the Part 2 of this webinar series, because it marks the beginning of the verification of the risk controls your company has implemented (i.e. – Post “Design Freeze”).
Two-part Risk Management Training Webinar for ISO 14971:2019 – Part 1 of this webinar will be presented live on Tuesday, March 29 @ 9-10:30 am EDT. Part 2 of this webinar series will be presented live on Tuesday, April 5 at 9-10:30 am EDT. Purchase of this webinar series will grant the customer access to both live webinars. They will also receive the native slide decks and recording for the two webinars.
20-Question Quiz for Risk Management Training Webinar on ISO 14971:2019 – We updated our quiz for training effectiveness from a 10-question quiz to a 20-question quiz that is more comprehensive. Any person that purchases the 20-question quiz will receive a training certificate template and the answer key to our quiz.
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