MDSS EUROPEAN AUTHORIZED REPRESENTATIVE SERVICES MDSS CONSULTING   ENGLISH    GERMAN    CHINESE
News Updates
  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
    more


  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...more


    
HIGHLIGHTS
Keep up to date!

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!

AACC
August 01-03, 2017
San Diego, USA
Booth: #1941

RAPS
September 09-12, 2017
National Harbor, MD, USA
Booth #537


Join us!

MDSS Workshop (IVDR)
August 04, 2017
San Diego, USA
Read more...


MDSS Workshops (MDR)

End October, 2017
East Coast, USA




CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

Click here to
contact us





Conformity Assessment


The conformity assessment is of great importance for demonstrating that products are in compliance with the requirements of an EU directive. It is a mandatory requirement for the market access of medical devices. The directives define numerous minimal requirements in regards to product safety and medical-technical performance according to the intended use, which must be documented by the manufacturer.

The medical device directives (90/385/EEC, 93/42/EEC, 98/79/EC) require medical device manufacturers to assess the conformity according to the requirements stipulated in the applicable directive.

The aim of the conformity assessment is to achieve the CE marking and thus to demonstrate the marketability in the European Union.

Furthermore, the CE mark is also a "door opener" to numerous non-EU markets.

MDSS Consulting GmbH will support you with the selection of the appropriate conformity assessment procedure for your company and products.  
We provide competent support with the implementation of the selected procedure and assist you with necessary certifications by a Notified Body.

Please feel free to contact us if you would like to receive more information. We are looking forward to hearing from you.



OUR CONSULTING SERVICES IN OVERVIEW