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 satisfies standards EN ISO 9001 and ISO 13485. BTLock products which belong to Class I feature CE label, while 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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