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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
Book now
 to make sure you’re ready to survive and thrive!



EVENTS
Meet us!

MEDICA
November 13-16, 2017
Düsseldorf, Germany
Booth #10B05



Join us!

9. Medical Device Networking Meeting - 
a RAPS Roadshow
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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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