New member of our team – Maria Eklycke

Welcome Maria! Maria will be located at our Stockholm office, starting full time 26th of September, 2016.

IEC 82304-1 – Free breakfast seminar in Lund and Stockholm

Learn about the upcoming  standard IEC 82304-1 “Health Software – Part 1: General Requirements for Product Safety” –  a product standard for software-only medical devices.

The seminar will be held in Lund 27 september and in Stockholm 29 september. For more information and registration follow the links below:

Lund

Stockholm

Internal Audit ISO 13485:2016 – Training

The course will be held in Lund, 13-14 October.
For more information see the following link

MEDDEV 2.7/1 Rev. 4

The updated MEDDEV 2.7/1 Clinical Evaluation: A Guide for Manufacturers and Notified Bodies has now been published