Charles H. Paul is the President of C. H. Paul Consulting, Inc. – a regulatory, training, and technical documentation consulting firm. Charles is a management consultant, instructional designer and regulatory consultant and has led C. H. Paul Consulting, Inc. since its inception over 25 years ago. He regularly consults Read more
Medical Devices by their very nature must be safe for human use and must meet the requirements for which they have been designed. The process which identifies the risks associated with a medical device that could make the device unsafe or not function as intended is called Risk/Hazard Analysis.
21 CFR Section 820 requires that comprehensive risk analysis be performed as part of the medical device regulatory submissions process and throughout the product’s lifecycle. ISO 14971 is the risk management standard for medical devices. Its purpose is to help manufacturers establish a risk management process that can be used to identify hazards, estimate and evaluate risks, and develop, implement, and monitor the effectiveness of risk control measures. This webinar will discuss both the regulatory requirements and the process for conducting effective Risk/Hazard Analysis.
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.
At the completion of this webinar, participants will be able to discuss the importance of risk analysis in the design, development, and fielding of medical devices and most importantly to apply the risk management process to their medical device design operations.
• 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
What You Get:
• Training Materials
• Live Q&A Session with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
This webinar is applicable to the Medical Device industry. Specifically, this webinar is targeted to those staff members that are involved in the design, development, and fielding of medical devices in the marketplace from initial introduction to retirement. Position titles that this webinar will benefit include Associates, Managers, Directors, and Vice Presidents. The following positions are more descriptive of those applicable positions.
• Audit and Compliance Personnel / Risk Managers
• Research and Development Engineers
• Vice-Presidents, Directors, and Managers of medical device design functions
• Medical device marketing personnel