The Alliance of European Life Sciences boutique Law Firms is an alliance of independent European life sciences boutique firms from around Europe, active in all areas of life sciences and medical technology.

The Alliance was founded in 2011 and consists presently of eight law firms, uniting a unique team of lawyers with many years of experience as external and in-house counsel in a large variety of areas the life sciences industry.

Please see the contact page for more information.

Category - EN62304

14-08-2014medicaldeviceslegal

Updates, patches, add-ons, plugins & the Blue Guide

Here is some follow up on the previous Blue Guide post: the new version of the Blue Guide is the first to address software updates to CE marked products, including software. For the purpose of this blog this would typically be standalone software that constitutes a medical device in the meaning of MEDDEV 2.1/6. Harmonised standards […]

22-04-2013medicaldeviceslegal

Team NB FAQ on EN62304 standard for software lifecycle processes

Many companies developing medical software, especially the smaller app developers, have difficulties applying the EN62304 standard. For that reason a number of experts under the auspices of Team NB started work on an FAQ document shedding more light on how this standard works, as to enable companies to conduct more productive discussions with their notified […]