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News and Views June 2017

News and Views May 2017 - Latest Update



In-House Workshops
The "NEW CE" mark
Book now!
 to make sure you’re ready to survive and thrive



EVENTS
Meet us!

AACC
August 01-03, 2017
San Diego, USA
Booth: #1941

RAPS
September 09-12, 2017
National Harbor, MD, USA
Booth #537


Join us!

MDSS Workshop (IVDR)
August 04, 2017
San Diego, USA
Read more...


MDSS Workshops (MDR)

End October, 2017
East Coast, USA




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