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 secret to preventing medical device recalls or 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 related 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.
The secret to preventing medical device recalls or 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 related 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.
Charles H. Paul
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 with Fortune 500 pharmaceutical, medical device, and biotechnology firms assisting them in achieving human resource, regulatory, and operational excellence. He is a regular presenter of webinars and on-site seminars on a variety of related subjects from documentation development to establishing compliant preventive maintenance systems.
Understanding the Artificial Intelligence Landscape
Establishing Appropriate Quality Metrics and Key Performanc…
Holiday Stress and Loss: The Art of Stress Resilience in E…
Is Your Culture Working For or Against Your Success? If You…
OSHA Requirements for Supervisors, Project Leaders & HR - W…
Ultimate Persuasion Strategies! - Secret Influence Tools & …
Using High-Performance Coaching for Managers to Address Per…
Excel - 10 Key Worksheet Functions to Skyrocket Your Produc…
Transform Data into Insights: A Beginners Guide to Excel Pi…
Red flags that can render your OSHA Safety Program Complete…
Utilizing HR Metrics to Illustrate & Improve Human Resource…
The Human Element of Leadership in the Hybrid Work Experien…
How to Navigate Political Speech in the Workplace
What If Analysis Tools in Excel: Goal Seek, Solver, and Dat…
Project Management for administrative professionals
Mastering Year-End Payroll and Tax Compliance for 2024
How to Prepare For and Host a FDA Inspection and Respond to…
Eliminate Harmful And Unproductive Drama In The Workplace
3-Hour Virtual Seminar on Chat GPT for Project Management i…
The Anti-Kickback Statute: Enforcement and Recent Updates
FDA Technology Modernization Action Plan (TMAP) and Impact …
5 Key Components of Good Manufacturing Practices to obtain …
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Team Synergy: How to Harness Collective Intelligence to Max…
The Power Of Trust In The Workplace- Improving Your Career …
Managing Toxic & Other Employees Who Have Attitude Issues
Successful Strategies for FDA Expedited Pathways for Your D…
Protect Your Company With The End of the Year HR Checklist
Do's and Don'ts of Giving Effective Feedback for Performanc…
Onboarding is NOT Orientation - How to Improve the New Empl…
Improving Employee Engagement & Retention Through Stay Inte…
Building GMP Excellence: A Guide to Implementing Compliant …
Understanding cognitive load in medical device design
Human Error Reduction Techniques for Floor Supervisors
Excel Power Skills: Master Functions, Formulas, and Macros …
