is being presented by Erik Vollebregt, Partner, with Axon and airs on Tuesday, November 8th, 2011. For more details or to register for this event, please visit our site at www.fxconferences.com
EU medical devices regulation is very much in flux: the European Commission is working on the text of the recast of the medical devices directive (MDD), and work is underway on a new guidance on stand-alone software under the MDD. In the meantime, medical device companies are producing more software-enabled devices and software that might qualify as medical devices. Clinical institutions and others are developing an increasing number of medical apps and websites with diagnostic and therapeutic functionality. Given these developments, it is vital for companies and institutions to be aware of how these products are regulated, and to determine if and how their software products are regulated.
This audio conference presentation reviews the current EU rules for software related to or incorporated within medical devices, and also sheds light on where these regulations are likely headed in the future. Our speaker also discusses FDA guidance on mobile medical apps, and how it can help guide companies in their efforts in Europe.
