ISO Certificates – UNISIS CORP JAPAN

ISO CERTIFICATES / CE CERTIFIED /
U.S. FDA 510(k) clearances

Unisis subsequently developed an internationally recognized quality management system (QMS) to earn the trust of customers worldwide. Our internal QMS was also made more stringent as appropriate for a medical device manufacturer. We pledge to continue the uncompromising pursuit of excellence in response to customer demand for quality. Our confidence in that quest is based on the satisfaction, evaluation, and trust of our clients.

ISO9001

ISO13485

According to Regulation (EU) 2023/607 amending Regulations (EU) 2017/745,
the transitional period for MDR and the validity of certificates under Directive 93/42/EC (MDD) have been extended.

Device	Extended validity
All Class lll devices	31 Dec 2027
Class ll b devices, Class ll a devices and Class ls devices	31 Dec 2028

ISO CERTIFICATES / CE CERTIFIED /
U.S. FDA 510(k) clearances

ISO certificate

ISO9001

ISO13485

CE Marking

U.S. FDA 510(k) CLEARANCES

ISO CERTIFICATES / CE CERTIFIED /U.S. FDA 510(k) clearances

ISO certificate

ISO9001

ISO13485 #image_1168994522 { width: 100%; }

CE Marking

U.S. FDA 510(k) CLEARANCES

ISO CERTIFICATES / CE CERTIFIED /
U.S. FDA 510(k) clearances

ISO13485