Risk Management for Medical Devices: Best Practices to Make Your FMEA Process Work For You

This presentation will show you how to make the DFMEA process work for you, what value it has for each function in your organization (development, marketing, quality, etc.), and how to use the process to help focus your testing matrix to target the most critical aspects of the product's design and function, helping you deliver a higher quality design to your customers.

Areas Covered in the seminar:

• Why FMEAs are required
• How to use a DFMEA/FMEA to help reduce risk
• The common mistakes in determining occurrence and severity rankings
• What you can and cannot affect to reduce your RPN (Risk Priority Number)
• Determining an RPN threshold
• Revising and updating your FMEAs

Who Will Benefit:

• Quality Assurance managers and personnel
• R&D managers & engineers
• Quality system auditors

Instructor Profile:

Robert DiNitto, is a principal and one of the founders of AlvaMed, LLC, an innovative medical technology consulting firm. He leads AlvaMed’s QA/RA and Design Control practice, having over 35 years of experience in the medical device industry.

Bob has developed and implemented design control systems that have been well received by both engineering organizations and regulatory auditors, and received a high approval rating from an FDA auditor. His engineering experience, in roles ranging from project engineer to VP of R&D, covers many types of products from small, portable monitors with sterile disposables to large x-ray systems. He has designed electrical and mechanical hardware and software.

Bob has assisted numerous companies with development planning, including providing training and document templates for development, V&V, manufacturing, risk management, and regulatory plans as well as conducting hazard analyses and FMEAs, developing appropriate, easy-to-use risk rating scales and training personnel on risk analysis basics.

Follow us :