At the end of January 2012, the European Commission published MEDDEV 2.1/6. This document is designed to provide a frame of reference for stand-alone software under the three medical device directives, which is important for compliance purposes. Many companies coming from a software background are new to medical device regulations and lack the tools for compliance. Since software that assists a medical device in its function also is regulated as a medical device, an understanding of medical device regulation is critical for vendors of software used in clinical settings. In this webcast, Erik Vollebregt, a Dutch lawyer specialised in EU legal matters related to medical devices, will discuss in detail the regulatory issues surrounding stand-alone software and explain how MEDDEV 2.1/6 helps manufacturers achieve compliance and where it may fall short. Attendees will come away from the one-hour session with a clear understanding of compliance as it relates to stand-alone software from a legal perspective.

Erik Vollebregt is a founding partner of Amsterdam-based Axon Lawyers, a boutique law firm that focuses entirely on the life sciences industry. He is specialised in legal, regulatory and IP issues involving the life sciences with a focus in biotechnology and medical devices. He also maintains the blog.

The one-hour webcast will include a question and answer session and will be moderated by Norbert Sparrow, Editor in Chief, EMDT and medtechinsider.

Webcast Details:

This pay-per-view webcast will take place on Tuesday, April 24 at 14:00 London/15:00 Paris.

Attendance is € 99 per person. EARLY BIRD SPECIAL: Register Before 16 April & Save €50!

*Please note: Credit card charges will appear in US dollars.

Group rates are also available.

Contact Briana Cosofret for information:, +1 (516) 562-5110.


Erik Vollebregt

Erik Vollebregt
Partner, Axon Lawyers

For more information about our speaker, please click here


Norbert Sparrow

Norbert Sparrow
Editor in Chief, EMDT and medtechinsider, UBM Canon

For more information about our moderator, please click here

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Price Per Person: € 99
*Please note: Credit card charges will appear in US dollars.

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