This message is sent to you by FDA Newswatch

Safety Engineering Fundamentals for Medical Devices

Friday, 20 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!

The challenges faced by medical device manufacturers in bringing safe devices at low life-cycle cost products to market in a timely manner is increasing rapidly. The increasing complexity and software criticality of medical devices is driving the need for a proactive practice of risk prevention.

However, theoretical knowledge is not enough. This webinar covers strategies for proactive thinking and doing, avoiding mistakes in developing safety specifications, avoiding mistakes in safety testing, and developing design policy for safe products. It presents examples from presenter's experience of over 30 years in the medical device, consumer, and aerospace industry.

Learning Objectives:

  • Establish good practices for design for safety
  • Learn to write good safety requirements in the specifications
  • Learn the correct way to use the tools for risk analysis
  • Learn to qualify manufacturing processes for safety
  • Learn to qualify suppliers for safety
  • Establish procedures for validating device design with a high degree of assurance
  • Establish adequate procedures for device safety audits
  • Establish procedures for finished device acceptance after each production run

Why Should You Attend:

Medical device safety recalls can cost billions. Millions of devices are recalled every year. Perhaps most striking is the fact that about one-third face multiple recalls. It is a reminder that recalls can happen to any company-especially as more and more companies turn to outsourcing.

A division of a highly reputable company paid over 4 billion dollars just to settle 8,000 lawsuits for hip joint device recall which resulted in severe pain and injury to the users from metallic debris generated. Understanding the fundamentals of safety engineering can make a tremendous difference in saving lives and help companies avoid costs of recall.

Areas Covered

  • Introduction to medical device requirements
  • Developing good safety specification early in design
  • Risk assessment and risk management techniques
  • Enhancing device robustness during the detail design
  • Designing for prognostics to protect patients
  • Preventing production safety defects
  • Preventing software failures in design
  • Preventing supply chain safety defects
  • Developing verification and validation plans
  • Role of management in implementing safety requirements
  • Innovation methods useful in preventing hazards


Dev Raheja

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.