Commitment to quality

BTI is committed to maintaining the high quality of its products and offering every possible guarantee to health professionals and patients.

Know more
Home >
About BTI >
Quality certificates >

All BTI's products undergo the most strict inspections, allowing us to offer customers products whose effectiveness and safety is fully guaranteed, and which comply with the most strict standards in each and every one of the countries it is present.

Quality Certificates

The quality system of BTI guarantees the excellence of its products throughout their life cycle, from their design to their commercialisation.


Our products carry the CE marking of compliance with the European Directive on PS (93/42 / CEE) and are also manufactured under a specific quality system for medical devices (based on ISO 13485:2016 and MDSAP) approved by TÜV SÜD Product Service GmbH.

BTI 2019 11 ec certificate tuv sud

Quality Certificates