News

14.10.16

Minisymposium: The new European Medical Device Directive

The reorganization of medical device certification in Europe is gathering speed. The new European Directive is expected to be published in the last quarter of 2016. Medical device manufacturers should prepare for the expected changes in order to initiate the right steps at the right time during the transition period.

Our symposium will provide an overview of regulatory changes, especially those associated with far-reaching consequences. We will inform you about the current status of the practical implementation of these reforms and address the subject from a legal perspective as well as from the point of view of a notified body. 

The symposium will also focus on changes regarding the clinical evaluation of medical devices and market surveillance. Profound consequences are also expected in the area of quality management systems and, with the introduction of the Unique Device Identification (UDI), in logistics processes as well.  In the course of the symposium we will provide you with up-to-date information and point out potential pitfalls and needs for interpretation. There will be sufficient time for discussion and questions on this important topic.

 

Date: 28.11.2016                            

Time: 16.00 Uhr - 19.00 Uhr            

Organizer: Schrack & Partner                   

Event location: Reutlingen TTR, Gehard- Kindler-Str. 6, 72779 Reutlingen

 

Date: 29.11.2016                            

Time: 16.00 Uhr - 19.00 Uhr            

Organizer: DEKRA Certification GmbH            

Event location: Intercity Hotel Frankfurt Airport, Am Luftbrückendenkmal 1, 60549 Frankfurt/Main

 

Attendance fee: 70,00 € (excl. 19 % VAT) per person

Registration until November 18, 2016

via E-Mail: info schrack-partner.eu

Fax: 07121 / 5106899

Postal: Schrack & Partner / Gerhard-Kindler-Str. 6 / 72770 Reutlingen

 

Please provide details on date and venue.

Detailed information (German only) can be found here.