Dev Raheja

Speaker: Dev Raheja

Webinar Code: OCH 100 401

Webinar Duration: 60(Minutes)

Risk Analysis and Risk Mitigation

Webinar Date: Friday 6th of September 2019 10:00 AM PDT | 01:00 PM EDT
Available Options
{ For One participant }

{ Unlimited Access for Six months }

{ Live + Recorded webinar }

{ Live Access for 10 Participants }



The specifications usually miss about 60% requirements. Therefore risk risks are inherent in design, manufacturing, and device use even after so much attention paid to the design control process. You can identify more risks than you know if you use the right process for risk analysis. The next step in design control is to design out risks by designing in the risk mitigation strategies.  Understanding how mishaps can happen before they happen and preventing them by design is the key to efficient risk management.

Why should you attend?

Understanding the best practices is a profound knowledge. This webinar is conducted by the international risk management consultant and the author of the text Preventing Medical Device Recalls.


  • Introduction to ISO 1491
  • Risk analysis techniques
  • Risk mitigation strategies
  • Developing risk acceptance criteria
  • Preliminary Hazard Analysis
  • Fault Tree Analysis
  • Failure Mode, Effects, and Criticality Analysis
  • Hazard Analysis and Critical Control Point process
  • Hazard and operability study (HAZOP) process
  • Mitigating risks to patients by designing for prognostics
  • Innovation methods in risk mitigation
  • Role of management in risk monitoring


Who should attend?

  • If you want to be efficient, the entire cross functional team should attend. But any of the following can attend:
  • Senior management
  • Design managers and engineers
  • Manufacturing managers and engineers
  • Quality Assurance staff
  • Regulatory affairs staff
  • Service engineering managers and engineers
Dev Raheja, MS,CSP, is an international Risk Management and Quality Assurance consultant for Healthcare, medical device, and aerospace industry for over 25 years. He applies evidence base safety techniques from a variety of industries to healthcare. 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