Our quality standards are very high. We place great value onconstant optimisation in order to always provide the best possible service.
We conscientiously take care of the implementation and compliance with DIN ISO standards, the complete documentation and archiving of each individual test procedure. We attach great importance to the training and further education of our staff in order to meet our high quality standards. In addition, we regularly participate in internal and external quality controls such as interlaboratory tests.
Our accredited test procedures
Medical devices are tested by BerlinAnalytix GmbH in accordance with DIN EN ISO 10993-6 (Biological evaluation of medical devices - Part 6: Testing for local effects after implantation). The medical devices we test come from various medical specialties such as (dental) surgery and wound care. They include resorbable and non-resorbable materials, as well as synthetic, biological and combined products (including metal implants in orthopaedics and dentistry, dental barrier membranes, bone replacement materials, vascular prostheses, wound dressings and covers).
BerlinAnalytix is pleased to be measured by the following certificates:
Certificates (PDF)
Certificate of successful accreditation according to DIN EN ISO/IEC 17025:2018 for testing laboratories
Our test laboratory offers also different other analyses, which is validated within the quality management system and which is proven especially in comparative tests of medical devices available on the market or newly developed.
These tests can be adapted flexibly in cooperation with customer requirements without compromising the quality standards of the testing laboratory.
