MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
    
HIGHLIGHTS
Keep up to date!

THE "NEW" CE MARKING
Get your questions answered for the NEW MD REGULATION – THE MDR!!!
more...


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



EVENTS
Meet us!

Arab Health
January 29-01 February, 2018
Dubai
Booth #Z3.D19



Join us!

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

more...

10. Medical Device Networking Meeting - 
a RAPS Roadshow 
December 04, 2017
Ulm, Germany

more...



CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

Click here to
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