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Risk based software verification – ISO14971 and IEC62304

December 19, 2013 @ 10:00 am - 3:00 pm

Why Should You Attend: Risk based verification allows organizations to optimize the verification effort and cost. Any verification has to allocate existing resources and often verification is performed extensively on unimportant or obvious system functions. Risk based verification optimizes this process by emphasizing the amount of rigor during testing based on the identification of critical system parts and functions. The result will be a more thoroughly verified software system and an increased coverage rate of system components that are essential and safety critical. This webinar will discuss the risk based verification techniques and will provide the practical tips for verifying system and software requirements. Areas Covered in the Webinar: -Residual risk identification and declaration -Risk based verification techniques -Objective based 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 Personnel -Compliance Managers -Regulatory and Compliance Associates Instructor Profile: Markus Weber, Principal Consultant with System Safety, Inc., specializes in safety engineering and risk management for critical medical devices. Mr. Weber 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, he 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. He has helped multiple companies, from startups to Fortune 500 firms. Topic Background: 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 risk based verification approach activities at the end of the device development can be streamlined and the time to market can be shortened without compromising the safety or effectiveness of the medical device. For Registration:http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=703201?channel=limesfinder


December 19, 2013
10:00 am - 3:00 pm
Event Category: