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.
2-Hour Virtual Seminar on How to Conduct an Internal Harass…
Cleanroom, Microbiology and Sterility Assurance Practices f…
Workplace Investigations 101: How to Conduct your Investiga…
Successfully Negotiating the Labor Agreement
Wage And Hour Laws: Ensuring Compliance With The Fair Labor…
Understanding the incredible uses and fallbacks of ChatGPT
5 Key Components of Good Manufacturing Practices to obtain …
How to Manage Conflict in the Workplace
Neutralizing Harassment - How to Promote the Proactive Pers…
Changing Behavior: Why Rewards and Punishments Often Aren't…
Human Error Reduction Techniques for Floor Supervisors
Hybrid Workplace: 10 Best Practices to Manage Your Team’s P…
Using Better Managerial Decision Making - to get great resu…
Excel - Pivot Tables - The Key To Modern Data Analysis and …
Using High-Performance Coaching for Managers to Address Per…
Form W-9 Compliance to Avoid Penalties: TIN Verification, B…
Using Stay Interviews To Improve Employee Retention & Engag…
FDA Technology Modernization Action Plan (TMAP) and Impact …
FDA Audit Best Practices - Do's and Don'ts
Stay Interviews: A Powerful and Low-Cost Employee Engagemen…
Become an excellent Critical Thinker to greatly improve you…
Learn the Do's and Don'ts of Opening Business Bank Accounts
Project Management for HR, Administrative Professionals, an…
Writing Effective 483 and Warning Letter Responses
Dealing With Difficult People In Life & Work
Managing Toxic & Other Employees Who Have Attitude Issues