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.
03/20/2018 10:00 AMTraining Topic: Developing an Effective Risk Management Plan for Medical DevicesInstructor: Daniel O'Leary
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
Risk Management Team Members
Design Project Team Members
Attendees receive a checklist to help ensure a correctly written Risk Management Plan.