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Reliability Engineering Fundamentals for Medical Devices

Friday, 06 July 2018 10:00 AM PDT, 01:00 PM EDT

Training Duration = 90 min                  Sponsored by Online Compliance Panel

Click Here to register $250.00

Click Here to register and receive CD recording $500.00

Shocking news about failures of medical devices. The FDA recalled more devices in the first quarter of 2018 than the entire year 2017!

Reliability has become a worldwide goal regardless of the industry. The engineering managers are intent on harvesting the value proposition for competing globally while significantly lowering the life cycle costs.

The reliability fundamentals are based on proactively preventing hardware failures, software failures, and product malfunctions. Most experienced engineers are expert in a segment of the field, but urgently need to understand the entire science of reliability. This is obvious from the continuously increasing number of medical device recalls by the FDA for over the last 20 years.

This webinar on Reliability Engineering Fundamentals for Medical Devices will cover the science and techniques for designing highly reliable medical devices at lower cost and in lesser time.

Learning Objectives:

  • Failure prevention
  • Design requirements analysis
  • Designing right the first time
  • Software reliability
  • Manufacturing reliability
  • Life cycle costs reduction
  • Design for trustworthiness
  • Product durability

Why Should You Attend:

An average of three medical devices recalls taking place every day! This is too hazardous for the millions of patients. It is too costly for manufacturers of the devices. The science of reliability engineering requires creativity and innovative skills to aim at zero failures and elegant solutions that produce a high return on investment. Reliability is the final proof of efficiency and efficacy of a product.

During this training, you will discover why statistical reliability predictions rarely correlate with field performance, how to make big reductions in warranty costs, how to eliminate failures during early design, how to select proper tests for production screening, how to set up accelerated life tests, how to manage reliability growth, and how to predict the product life.

Areas Covered

  • The new paradigms for designing for reliability
  • How to write good engineering specifications
  • How to write manufacturing specifications for defect free production
  • How to use failure prevention tools
  • Failure mode, effects, and criticality analysis
  • Develop design and manufacturing reliability validation tests
  • How to use creativity for design solutions that cost very little or nothing
  • Case histories of zero failures at low costs


Dev Raheja, MS,CSP, author of the books Safer Hospital Care and Preventing Medical Device Recalls, 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, and at Booz-Allen & Hamilton as Risk Management consultant for variety of systems. Currently he is an Adjunct Professor at the Florida Tech for its BBA degree in Healthcare Management and the online faculty at University of Maryland where he teaches courses on Reliability.

He is a Founding Fellow of American College of Healthcare Trustees and a member of American College of Healthcare Executives, 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. He helped them in providing 24/7 access to family members of patients and reduced the number of alarms for nurses so they recognize critical patient needs early.