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



Cosmetic Products in Europe

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EVENTS
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MDSS Workshops
February 09, 2018
Costa Mesa, CA, USA

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February 12, 2018
Redwood City, CA, USA

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Medizinprodukteverordnung (MPV)
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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




CONTACT

MDSS GmbH
Schiffgraben 41
30175 Hannover
Germany

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

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Usability


In the area of medical technology, usability means the intuitive use of a medical device, putting first the efficiency and effectiveness for patients, users and third parties. 

"Usability tests" under typical terms of use or an assessment based on clinical experiences with previous products are only two of the possible approaches. Depending on primary and secondary objectives, clinical investigations or observational studies are also suitable for verification and validation of the usability of a medical device.

The EN IEC 60601-1-6 standard initially required the assessment of the usability for active medical devices. Currently, the EN ISO 62366 standard is applicable for all medical devices and has established the term "Usability" as fixed concept the medical technology.

As MDSS Consulting GmbH, we advise you and make recommendations.


OUR CONSULTING SERVICES IN OVERVIEW