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  • Looking for a suitable GMDN-Code?
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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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HIGHLIGHTS
"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"
Book now
 to make sure you’re ready to survive and thrive!


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Cosmetic Products in Europe

Latest News



EVENTS
Join us!

MDSS Roadshow:
- St- Paul, MN
MDR workshop
May 21, 2019

- New Jersey
MDR workshop
May 23, 2019

- Anaheim, CA
IVDR workshop
August 9, 2019
______________________


Meet us!

AACC
August 6-8, 2019
Anaheim, CA
Booth #1709

RAPS
September 21-24, 2019
Philadelphia
Booth#200




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