Preview this audio conference

The following is a brief excerpt from this audio conference. It is in mp3 format and will play with most media players. Please Contact Us with any questions you may have.

Click the file name to listen to the excerpt ac20080221_sample.mp3

Audio conference highlights

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.

In this audio conference, Mr. Weber discusses the elements of risk management, the current interpretations of regulatory requirements, as well as advice on implementation of a compliant risk management process. ISO 14971:2007 helps companies input risk management strategies, it can help many types of businesses from software-based to broadband provision-related enterprises working with devices. Additionally, the presentation provides practical tips to comply with ISO14971, implement risk management, and minimize the administrative burdens imposed to handle the additional process.

This audio conference covers:

• 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

About the speaker:

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, implement successful risk management processes.

Who should attend?

• Project Managers
• System Engineers
• Regulatory Affairs
• Compliance Managers
• Regulatory and Compliance Associates

This conference is rated General interest