Failure Mode and Effects Analysis for Design Improvement and Design Control

Instructor: Dev Raheja
Product ID: 701988
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

In this failure mode and effects analysis training, attendees will learn how to design medical devices that enhance reliability, durability, safety, and serviceability. They will also gain a solid understanding of both the Design FMEA, and the Process FMEA.

Why Should You Attend:

Risk analysis is now required by law (GMP). Identification of device design problems prior to distribution eliminates costs associated with warranties, product recalls, and product validation.

FMEA (Failure Modes and Effects Analysis) can reveal missing requirements, vague requirements, missing functions, and point out component and manufacturing problems well before process validation. These in turn reduce life cycle costs and reduce the time to market. Design FMEA serves as a central document in the design control process. Similarly the Process FMEA serves as the central document in the process validation qualification.

This webinar will detail how you can design medical devices that enhance reliability, durability, safety, and serviceability. The course will cover both the Design FMEA, and the Process FMEA.

Learning Objectives:

  • Learn to avoid warranty costs
  • Understand how to use FMEA correctly
  • Avoid classic mistakes that waste time and produce ineffective results
  • Capture new risks
  • Learn the art of elegant problem solving
  • Learn to minimize inspection and testing
  • Help management in risk evaluation and decisions on marketing the product

Areas Covered in the Webinar:

  • FMEA procedure-the right way
  • The wrong practices in FMEA
  • Using FMEA to improve the design
  • New paradigms for design improvement
  • Using FMEA for design inputs
  • Using FMEA for verifying design outputs
  • Avoiding wrong practices FMEA practices for efficient results
  • Identifying critical design features
  • Using best strategies to mitigate risks
  • FMEA for planning design validation

Who Will Benefit:

This course is designed for all technical employees. This is particularly important for all managers because 85% device defects are said to be the result of poor management practices. The following personnel will benefit from the course:

  • Senior managers
  • Quality assurance supervisors
  • Design engineers
  • R&D engineers
  • Production supervisors
  • Quality professionals
  • Regulatory professionals
  • Compliance professionals
  • Manufacturing engineers
  • Production engineers
  • Quality auditors
  • Document control specialists

Instructor Profile:

Dev Raheja, MS,CSP, author of the books Preventing Medical Device Recalls and Safer Hospital Care, is an international risk management, patient safety and quality assurance consultant for medical device, healthcare and aerospace industry for over 25 years. Prior to becoming a consultant in 1982, he worked at GE Healthcare as supervisor of quality assurance/manager of manufacturing engineering, at Cooper Industries as chief engineer, and at Booz-Allen & Hamilton as risk management consultant for a variety of industries.

His clients include Johnson & Johnson, Siemens Medical Systems, Medtronic, Carl Zeiss, Warner-Lambert, Zimmer Holdings, and DuPont. He has served as adjunct professor at the University of Maryland for five years for its PhD program in reliability engineering. He is a Fellow of American Society for Quality and recipient of its Austin Bonis Award for Reliability Education Advancement, former chair of the Reliability Division, and member of the Biomedical Division. He is a senior member of IEEE. Currently, Mr. Raheja serves as an adjunct professor at the Florida Tech for its BBA degree in healthcare management, and has authored two more books - Assurance Technologies Principles and Practices; and Zen and the Art of Breakthrough Quality Management. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from the System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He serves on the Patient and Families Advisory Council at Johns Hopkins Hospital and is a member of American College of Healthcare Executives.

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