Risk Assessment for Medical Devices

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.

Why You Should 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 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.

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
• 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

Who Should Attend:

• Research and Development Departments
• Quality Departments
• Manufacturing Departments
• Engineering Departments
• Operations Departments
• Design and Development Teams
• Document Control Professionals

Course Director: CHARLES H. PAUL

Charles Paul is an instructional designer and management consultant with over 30 years’ experience providing training and consulting services to regulated industries. He has installed quality systems and designed and developed GMP and operational documentation and training programs for foods and beverage, pharmaceuticals, biotech, cosmetics, and consumer product – OTC industries.