Residual Risk and Risk based Verification

Markus Weber
Instructor Markus Weber
Product Id W11
Duration 60 Minutes  
Version Recorded
Original Price $295
Special Offer Price $10
Refund Policy
Access recorded version only for one participant; unlimited viewing for 6 months

Residual Risk and Risk based Verification

Overview:
Learn how to define the residual risk of your device and how to streamline the verification process by employing a risk based approach.

Adjusting the verification process to account for the criticality of the verified items can drastically reduce the overall cost and time for verification activities. By implementing a risk based verification approach activities at the end of the device development can be streamlines and the time to market can be shortened without compromising the safety or effectiveness of the medical device.

Areas Covered in the Session:
  • Residual risk identification and declaration
  • Risk based verification techniques
  • Objective base verification planning
  • Documentation of verification activities
  • Practical tips for verifying system and software requirements
Who Will Benefit:
  • Project Managers
  • System Engineers
  • Test and Verification Engineers
  • Regulatory Affairs
  • Compliance Managers
  • Regulatory and Compliance Associates
Speaker Profile
Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. He graduated from Ruhr University in Bochum, Germany with a MS in Electrical Engineering. Before founding System Safety, Inc., he was a software safety engineer for the German approval agency, TUV. Since 1991, Mr. Weber has been a leading consultant to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. In conjunction with the FDA, he has published works on risk management issues and software-related risk mitigations. Mr. Weber has helped multiple companies, from startups to Fortune 500 firms.

Sign Up for Our Newsletter