Complying with EU Requirements for Medical Device Software

is being presented by Poul Schmidt-Andersen, Managing Partner, with Danish Medical Devices Consulting and airs on Thursday, September 29th, 2011. For more details, or to register please visit our site at www.fxconferences.com

This audio conference presentation highlights the new European Union requirements for software systems arising from the latest amendments to the Medical Devices Directive (MDD). The presentation focuses on how software should be designed to ensure the repeatability, reliability and performance of systems according to the intended use. Our speaker also addresses how, in the event of a single fault condition in the system, appropriate means can be adopted and documented to show that risk has been eliminated or reduced as far as possible. The presentation also covers how to establish suitable documentation to demonstrate compliance and satisfy Notified Body reviewers.