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.
Unisis received ISO9002:1994 and ISO13488:1994 accreditation in 1997. Accreditation was upgraded to ISO9001:2015 and ISO13485:2016.
We obtained CE marking in 2006. We are accordingly implementing MDD requirements.
U.S. FDA 510(k) CLEARANCES
We have received U.S. FDA 510(k) clearances on Disposable Spinal Anesthesia Needle, Disposable Epidural Anesthesia Needle and Disposable Nerve Blockade Needle.