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.
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