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 test procedures
Medical devices are tested by BerlinAnalytix GmbH according to ISO guidelines 10993-6 (implantation). The medical devices we test come from various medical fields, such as dental surgery and wound care. They include resordable and non-resordable materials, as well as synthetic, biological, and combined products (including implants in orthopaedics and dentistry, dental barrier membranes, bone substitute materials, vascular prostheses, wound fillers and covers, and many more).
BerlinAnalytix is pleased to be measured by the following certificates:
Certificates (PDF)
Certificate of compliance with the criteria of the quality assurance system DIN EN ISO 9001
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.
