Failure Mode and Effects Analysis for Design Excellence in Medical Devices

Duration: 90 Minutes
In this webinar "Failure Mode and Effects Analysis for Design Excellence in Medical Devices," attendees will learn how to design medical devices that enhance reliability, safety, durability and serviceability. They will also gain a thorough understanding of both the Design FMEA, and the Process FMEA.
FMEA for Design Improvement
Instructor: Dev Raheja
Product ID: 500997

Areas Covered
  • The wrong practices in FMEA
  • FMEA procedure-the right way
  • Using FMEA to improve the design specifications
  • New paradigms for design improvement
  • Using FMEA for verifying design outputs
  • Using FMEA for design inputs
  • Avoiding wrong practices FMEA practices for efficient results
  • Identifying critical design features
  • Using best strategies to mitigate risks
  • FMEA for Planning Design Validation
  • FMEA to avoid manufacturing defects

Why Should you Attend
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. 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.

Objectives of the Presentation
  • 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
Who can 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:
  • Quality assurance supervisors
  • Senior Managers
  • Design Engineers
  • Production Supervisors
  • R&D Engineers
  • Quality Professionals
  • Compliance Professionals
  • Regulatory Professionals
  • Manufacturing Engineers
  • Quality Auditors
  • Production Engineers
  • Document Control Specialists
$375
Recorded Session for one participant
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  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
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  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
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 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 and is Senior Member of IEEE. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management, has authored two more books Assurance Technologies Principles and Practices, and Safer Hospital Caret. He has received several industry awards including the Scientific Achievement Award and Educator-of-the Year Award from System Safety Society. He is a former National Malcolm Baldrige Quality Award Examiner in the first batch of examiners. He has done seminars on Risk Management, Process Validation, Software Reliability, Software Safety, Design Control, and Corrective and Preventive Action (CAPA) System.
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