Quality is an essential point for all companies, but it is a matter of life when medical devices are involved. According to the regulations of the directive 93/42/ECC UE, the conformity of the medical devices has to be assessed before entering the market.

The preferred method is a conformity certification by a notifying body (CAB, Conformity Assessment Body).

BTLock conformity with EN ISO 9001 and ISO 13485 is certified by Det Norske Veritas (certificate n° CERT-14156-2004-AQVEN- SINCERT and CERT-18603-2007-AQ-VEN-SINCERT). Det Norske Veritas (DNV) is a Norwegian certification body, which started its activities in 1864. It is the second certifying body in the world for number of released certifications. The BTLock products which belong to Class I feature CE label, while the BTLock products which belong to Classes IIA and IIB are CE certified by the Istituto Superiore di Sanità (Notifying body n° 0373 - Italian Ministry of Health).

The request for international distribution has brought BTLock to conform its production also to extra-UE standards in order to obtain the registration in foreign markets such as Taiwan, South Korea, Brasil, and the United States of America.