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  • Looking for a suitable GMDN-Code?
    MDSS can assist you to determine an appropriate code for your products!
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  • MDSS, may support you with the process of applying for a Free Sales Certificate/Certificate of Marketability...
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THE "NEW" CE MARKING
Get your questions answered for the NEW REGULATION 
– THE MDR/IVDR!!!

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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!



Cosmetic Products in Europe

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EVENTS
Meet us!

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


MD&M West
February 06-08, 2018
Anaheim, CA, USA
Booth #1969


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MDSS Workshops
Medizinprodukteverordnung (MPV)
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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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contact us





Risk Management



The handling of the subject of risk management is closely interlocked with the medical device: From the initial idea of the whole product life cycle (development, production, marketing and use, through to the disposal).

These observations contain all possible risks for patients, users or others who are related with the product. DIN EN ISO 14971 offers the basis for a comprehensive risk management process for medical device manufacturers.

MDSS Consulting GmbH can assist your employees and reduce their workload in every phase of this process with its competent support. Our competence team offers wide-ranging expertise in device development and production, in device management as well as in the use of medical devices and post Market Surveillance.


The development of a tailored risk management procedure includes: 
  • risk management plan
  • risk analysis
  • risk assessment
  • risk minimization strategies
  • risk/benefit assessment
  • risk management report
  • risk management file

Our moderation of risk management processes  in your company contains: 
  • identification of risks
  • definition of measures
  • evaluation of measures

If you would like to receive further information about this service, feel free to use our contact form. We are looking forward to hearing from you.




 

OUR CONSULTING SERVICES IN OVERVIEW