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THE "NEW" CE MARKING
Get your questions answered for the NEW MD REGULATION – THE MDR!!!
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In-House Workshops
The "NEW" CE MARKING
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 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

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

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CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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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