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.
Best Practices for Implementing ISO14971:2007 was presented by Markus Weber, Principal Consultant, with System Safety Inc. and aired on 2008-02-21. For more details or to download this event, please visit our site at www.fxconferences.com