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 medicaldeviceslegal.com 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.
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: Briana.Cosofret@ubm.com, +1 (516) 562-5110.
Partner, Axon Lawyers
For more information about our speaker, please click here
Editor in Chief, EMDT and medtechinsider, UBM Canon
For more information about our moderator, please click here
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