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).
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When is the Risk Management Procedure Webinar?
The Risk Management Procedure Webinar will be hosted on September 9, 2024 @ 10:30 a.m. ET. The webinar will be live on StreamYard, and you will receive login instructions if you purchased the training procedure prior to the scheduled live webinar. The webinar will also be recorded. You will be able to download the webinar from our Dropbox folder and watch the webinar as many times as needed–including the training of future employees.
What’s included in the purchase of this procedure?
The following documents are included with the purchase of this procedure:
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/IVD, ISO 14971:2019, and ISO/TR 24971:2020. This procedure is the primary document meeting the applicable regulatory requirements for risk management 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
- benefit-risk 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
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”).
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About Your Instructor
Rob Packard is a regulatory consultant with ~25 years of experience in the medical device, pharmaceutical, and biotechnology industries. He is a graduate of UConn in Chemical Engineering. Rob was a senior manager at several medical device companies—including the President/CEO of a laparoscopic imaging company. His Quality Management System expertise covers all aspects of developing, training, implementing, and maintaining ISO 13485 and ISO 14971 certifications. From 2009 to 2012, he was a lead auditor and instructor for one of the largest Notified Bodies. Rob’s specialty is regulatory submissions for high-risk medical devices, such as implants and drug/device combination products for CE marking applications, Canadian medical device applications, and 510(k) submissions. The most favorite part of his job is training others. He can be reached via phone at +1.802.258.1881 or by email. You can also follow him on YouTube, LinkedIn, or Twitter.