Developing an Effective Risk Management Plan for Medical Devices

Duration: 90 Minutes
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This presentation gives you the essential information to write a successful Risk Management Plan. Don't skip required items or add additional, but unnecessary information. If the item doesn't apply, so why. Don't include extraneous information such as market size and share; they are not relevant. The Risk Management Plan is key for an efficacious project that helps to ensure your device is safe and meets the regulatory requirements.
Effective Risk Management Plan
Instructor: Daniel O'Leary
Product ID: 504500
Objectives of the Presentation
  • The scope of the plan and its relationship to the device life-cycle
  • Assignment of responsibilities and authorities and a valuable tool to help manage them
  • When and how to review risk management activities
  • Establishing the criteria for risk acceptability
  • Understanding risk evaluation in the EU and the international versions
  • Special cases of risk acceptability that can often reduce the risk management workload
  • The necessary verification activities (implementation and effectiveness) and how they can link to the QMS
  • Collection, review, evaluation, and action from production and post-production information collection
Why Should you Attend
The single most important element of the medical device risk management process is the Risk Management Plan (RMP). It ranges from Top Management's risk policy to review and approval of the Risk Management Report. Get these items wrong and the rest of the risk management process suffers from lack of information to make decisions or ensure qualified people are involved in the process. An ineffective process could result in an audit nonconformance from your Notified Body or even an FDA Warning Letter.

While there are six mandatory areas for the RMP and each requires specific information and involves some difficult decisions. While the mandatory areas don't change between ISO 14971:2007 and EN ISO 14971:2012, the details can be significantly different.

To create an effective Risk Management Plan (RMP), one must understand the details behind the mandatory areas. For example, there are many issues in defining risk acceptability. The application of risk evaluation and the need for risk control, for example, are different in the international version and the European version. A well-written and comprehensive plan offers significant contribution to the project's success.

Who will Benefit
  • Top Management
  • R&D Managers
  • Risk Managers
  • Project Managers
  • Risk Management Team Members
  • Design Project Team Members
  • Complaint Specialists
  • MDR Specialists
Bonus Material
Attendees receive a checklist to help ensure a correctly written Risk Management Plan.
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Instructor Profile:
Dan is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. He has a Masters Degree in Mathematics; is an ASQ certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.
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