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Recorded Webinar
Global Medical Device Risk Management - Demystifying European, FDA and ISO Requirements
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
The webinar will provide guidance for preparing medical device Risk Management Plans, Reports and Files in compliance with current international regulatory requirements.
The presentation will dissect the risk management requirements in ISO 14971:2007 (FDA Recognized) and contrast them with the requirements of the European Directives as pointed out in EN ISO 14971:2012.
After this session, the participants should be prepared to answer these questions for their organizations:
- Does your RM system require revision to address forgotten aspects of ISO 14971:2007 or the “content deviations” described in EN ISO 14971:2012?
- Do your existing RM files and subordinate documents require updates to conform with your (updated) procedures?
- What impact will the ISO/TR 24971:2013 guidance have on your RM system?
Webinar topics will include:
- Background
- General Requirements
- Risk Assessment
- Risk Control
- Risk/benefit Analysis
- Overall Residual Risk Evaluation
- Risk Management Report
- Production and Post-Production Information
Who should attend
Anyone who is interested in learning more on Medical Device Risk Management
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