Commitment to quality

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

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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

BTI's quality system ensures the excellence of its products throughout their life cycle, from design to disposal after fulfilling their intended use.


Our products are manufactured in accordance with ISO 13485 and MDSAP standards and meet the requirements of the European Medical Devices Directive MDD 93/42 and Regulation MDR 2017/745.

ISO Certificate 13485

Size 384.20 Kb

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MDSAP Certificate

Size 435.71 Kb

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MDD 93/42 Certificate

Size 91.13 Kb

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MDR 2017/745 Certificate

Size 297.75 Kb

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Quality Certificates