Risk Management in Medical Device Design
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.
January 24, 2020
10:00 AM PST | 01:00 PM EST
More Trainings by this Expert
Product Id : 502845
Live: One Dial-in One Attendee
Corporate Live: Any number of participants
Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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:
Who Will Benefit:
- Why Risk/Hazard Analysis is important
- Risk Assessment Defined
- Regulatory Requirements
- 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
- Risk Control/Mitigation
- R & D
- Management - essentially everyone in the organization that is involved in the design and development of medical devices
Charles H. Paul is the President of C. H. Paul Consulting, Inc. - a regulatory, manufacturing, training, and technical documentation consulting firm - celebrating its twentieth year in business in 2017. He has been a regulatory and management consultant and an Instructional Technologist for 30 years and has published numerous white papers on various regulatory and training subjects. The firm works with both domestic and international clients designing solutions for complex training and documentation issues.
He has held senior positions in consulting and in corporate training development prior to forming C. H. Paul Consulting, Inc. He also worked for several years in government contracting managing the development of significant Army-wide training development contracts impacting virtually all of the active Army and changing the training paradigm throughout the military.
He has dedicated his entire professional career explaining the benefits of performance-based training