PROSYSTEM provides Usability Engineering and verification from one hand.
Usability of medical devices attracts more and more the public and regulatory authorities. FDA studies revealed recently that a high number of incidents with medical devices arised from missuse of the product. The European Medical Device Directive 93/42/EEC revised by Directive 2007/47/EC counteracts this trend by including usability in the Essential Requirements. Since March 2010 medical device manufacturers have to assess usability during the product realization and adjust the products to the needs of the users.
IEC 62366 is the harmonized standard in Europe, demanding detailed requirements to the usability process for medical devices. Utilize our expert knowledge already at the beginning of your feasibility phase. The usability process begins here, not at the developed product! The involvement of your client and the product user is the key to success.
PROSYSTEM provides you the expertise during your product development and realization, develops validation strategies and conducts your usability studies.