Audio Conference

Best Practices for Implementing ISO14971:2007 Markus Weber Principal Consultant System Safety Inc. Recording - US$249

Purchase a recording of this Audio Conference

Implementing risk management into the medical device development process has become a regulatory necessity. However manufacturers still struggle to not only fulfill the requirements of ISO14971, but also to find ways to implement risk management into the overall operating framework in a meaningful way. In this audio conference, our speaker will discuss the elements of risk management, the regulatory requirements and current interpretations, as well as implementation of a compliant risk management process. Additionally, the presentation will provide practical tips to optimize the benefits of implementing risk management into the development process while at the same time minimizing the administrative burden imposed by the additional process.

This audio conference will address:

• 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

Speaker biography:

Markus Weber is Principal Consultant with System Safety, Inc. and is specialized in safety engineering and risk management for critical medical devices. He received an MS Electrical Engineering education at the Ruhr University in Bochum, Germany and worked for the German approval agency TUV as a software safety engineer before founding System Safety, Inc. Since 1991 he has consulted to the medical device industry on safety and regulatory compliance issues, specifically for active and software-controlled devices. He has published on risk management issues and software-related risk mitigations (jointly with FDA) and has implemented risk management processes in multiple companies (from Fortune 500 to start-ups).

Who Should Attend?

• Project Managers
• System Engineers
• Regulatory Affairs
• Compliance Managers
• Regulatory and Compliance Associates
  
  This audio conference is rated General Interest.
  

Purchase Options:

• Purchase a recording of this event US$249