Device Corrections and Removals -Webinar By GlobalCompliancePanel August 30, 2012

Overview: Learn how 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
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.

Official Website: http://bit.ly/RlThZp