The webinar will explore the basic principles of risk management and planning as they relate to medical device design and as required by the FDA. It will present a logical process for risk management from risk identification through evaluation/rating and mitigation.
Why should you Attend: The secret to preventing medical device recalls or at least to minimizing their impact is sound Risk/Hazard Analysis. Aside from being required, it is absolutely essential and necessary to the development and fielding of medical devices that offer a significant level of protection for patients and manufacturers alike.
The tools and techniques of Risk Analysis and the rating process used to evaluate the risks identified will be presented and discussed - Fault Tree Analysis, Failure Mode Effects Analysis, and Failure Mode Effects and Criticality Analysis.
Areas Covered in the Session:
Why Risk/Hazard Analysis is important
Risk Assessment Defined
Risk Management Process - The Risk Management Plan
Risk Management Documentation
Risk Analysis Processes and Techniques
Asking the Right Questions
The Evaluation/Analysis Tools - FTA, FMEA, and FMECA
- R & D
- Management - essentially everyone in the organization that is involved in the design and development of medical devices
• R & D
• Management - essentially everyone in the organization that is involved in the design and development of medical devices