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News and Views June 2017

News and Views May 2017 - Latest Update



In-House Workshops
The "NEW CE" mark
Book now!
 to make sure you’re ready to survive and thrive



EVENTS
Meet us!

MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



Join us!

RMD 2017 Europe
06-07 October, 2017
Berlin, Germany


9. Medical Device Networking Meeting - 
a RAPS Roadshow
November 30, 2017
Hannover, Germany

more...



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

Phone
(+49)-511-6262 8630
FAX
(+49) -511-6262 8633

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contact us





Technical Documentation


The technical documentation includes all documents and records, containing information about development, production, marketing, placing on the market, maintenance and service. It covers all stages of a product’s life cycle.

The certificates for products and modules as well as those of the suppliers, the labelling and marking, instructions for use, pre-clinical and clinical data as well as test certificates and results of testings, also belong to the technical documentation. Furthermore, the risk management dossier and usability evaluations are integral components of the technical documentation.

The technical documentation becomes therefore proof of fulfillment of the "essential requirements" of the respective medical device directive. In the course of product modifications or design reviews, the documentation is updated accordingly and thus provides information about the safety and performance of the medical device at any time.

MDSS Consulting GmbH compiles the supporting documentation based on your documents and points out insufficient contents to be supplemented, and supports your employees with the creation of additional documentation.



OUR CONSULTING SERVICES IN OVERVIEW