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Recorded Webinar
ISO 14971, Risk Management for Medical Devices
timelapse 60 mins with 10-15 mins of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
This webinar explains the application of Risk Management for medical devices using ISO 14971:2007. The webinar describes the flow of information in the Risk Management system looking at important terms including Hazard, Harm, and Risk and explaining how to use each one. The program describes a Risk Evaluation method that implements the requirements of ISO 14971:2007. The program covers the issues of risk reduction and explains the priority order.
This presentation will cover the following areas :
- Risk Management Plan.
- Risk Analysis.
- Risk Control.
- Overall Residual Risk.
- The Risk Management Report.
- Production Information collection.
- Post-production Information Collection.
Who should attend
Medical Device companies/professionals including :
- Risk Management
- Regulatory Affairs (Associates, Specialists, and Managers)
- Quality Professionals (Associates, Specialists, Auditors, Engineers, and Managers)
- Research and Development (R&D) (Engineers and Managers)
- Complaint Handling and Risk Management Professionals
- Technical Documentation
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