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



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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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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.


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