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Jasmin NUHIC
Sr. Compliance Quality Engineer, Medtronic

Markus Weber
Principal Consultant, System Safety Inc.

Mark Roberts
Founder, Roberts Consulting & Engineering

  Home > Webinars > Risk Management during device design according to ISO14971
Risk Management during device design according to ISO14971
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Training Options  Duration: 60 Minutes  
Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Price: $295.00
Refund Policy

by Markus Weber 
Overview: The presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

Learn how to put an effective risk management plan in place and fulfill the requirements of ISO14971

In the medical device development process, it has become a regulatory necessity to implement an effective risk management plan to fulfill the requirements of ISO14971. Manufacturers, however, still struggle to comply with ISO14971 and find a meaningful way to introduce risk management to the overall operating framework.

Areas Covered in the Session:

  • Basic principles of risk management
  • Risk management planning and procedures
  • Hazard and risk analysis
  • Documentation of risk management activities
  • Practical tips for implementing risk management processes

Who Will Benefit:

  • Project Managers
  • System Engineers
  • Regulatory Affairs
  • 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. 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.



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