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Commitment to Quality

BTI is dedicated to maintaining the superior quality of its products, offering the highest level of assurance to both health professionals and patients.

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All BTI products undergo the most rigorous inspections. This process allows us to offer customers products with fully guaranteed effectiveness and safety, ensuring compliance with the strictest standards in every country where we operate.

Quality Certificates

BTI's quality system guarantees the excellence of our products throughout their entire lifecycle, from initial design to final disposal after use.


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

ISO Certificate 13485

Size 342.50 Kb

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MDSAP Certificate

Size 423.67 Kb

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MDD 93/42 Certificate

Size 1.16 Mb

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MDR 2017/745 Certificate

Size 297.75 Kb

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Quality Certificates

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The information provided on this site is intended for use by healthcare professionals practicing in the US. The dissemination of this information may be subject to different medical and regulatory requirements in other countries.
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