BETTER MEDICAL DEVICES THROUGH EFFICIENT RISK MANAGEMENT AND RISK ANALYSIS

Complimentary Webinar

Speaker: Dev Raheja, MS, CSP Date: November 24th, 2014 Time: 1:00pm EST   Duration: 60 mins.

Webinar Description

·         Medical device recalls can cost billions. The number of medical device products affected by recalls hit an eight-quarter high in the second quarter of 2012, exceeding 100 million units.

·         Perhaps most striking is the fact that of the 140 medical device companies affected by recalls in the 90-day period in this quarter, one-third faced multiple recalls.

·         More than 10 million units were affected. It is a reminder that recalls can happen to any company—especially as more and more companies turn to outsourcing [1].

·         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. In addition, the company paid surgical expenses to those affected.

·         While most standards are helpful, they can be considered only minimum requirements where self interest prevails.

·         Even in healthcare where compliance to standards is at highest level, more patients die from medical mistakes each week than a jumbo jet crashing.

·         Understand how mishaps can happen before they happen & preventing them by design is key.

·          The FDA reviews the results of the performance tests during pre-market approvals, and in complaint investigations. Therefore a thorough understanding of designing medical devices for a long reliable and safe life by the entire staff is critical in efficient business strategy.

Your Expert Presenter

Dev Raheja, MS, CSP, author of the text Preventing Medical Device Recalls, is an international Risk Management and Quality Assurance consultant for the Healthcare, Medical Device, and Aerospace industry for over 25 years. He applies evidence based safety techniques from a variety of industries to the design of medical devices. He is a trainer, author of the books Safer Hospital Care, Assurance Technologies Principles and Practices, and Design for Reliability. He shows clients how to come up with elegant solutions using creativity and innovation. Being a true international consultant, he has conducted training in several countries including Sweden, Australia, Japan, Germany, UK, Singapore, Taiwan, South Africa, Finland, and Brazil. He helped a major Midwest company from going out of business to becoming a world leader by eliminating safety mishaps. Prior to becoming a consultant in 1982 he worked at GE Healthcare as Supervisor of Quality Assurance and Manager of Manufacturing, and at Booz-Allen &Hamilton as Risk Management consultant for nuclear and mass transportation industry. He is a member of IEEE, AAMI, and the System Safety Society: and received the Scientific Achievement Award and the Educator-of-the-Year Award from the System Safety Society.

Who Should Attend

• Senior Management
• Hardware and Software Engineers
• Technical Managers
• Regulatory Affairs Professionals
• Marketing Managers
• Service Managers
• Project Managers and Engineers
• Quality Assurance Staff
• IT Professionals looking to make the design process efficient