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.

Quality Certificates

ISO Certificate 13485

Size: 342.50 Kb

MDSAP Certificate

Size: 423.67 Kb

MDD 93/42 Certificate

Size: 1.16 Mb

MDR 2017/745 Certificate

Size: 533.65 Kb