The test laboratory for medical devices at IIB e.V.
Head of the accredited testing laboratory: Dr.-Ing. W. Schmidt
The Test Laboratory for Cardio+Vascular Products is an independent and autonomous laboratory integrated into the IIB. Its focus is physical testing of balloon catheters and stent systems used for the treatment of coronary artery disease and other vascular ailments.
The essential tests are subject to international standards (e.g. DIN EN ISO 25539-2), are established as standard operating procedures in the test laboratory and are used as validated tests for product approval in accordance with the terms of the Medical Devices Regulation (EU) 2017/745 (MDR). In addition, we also provide comparative tests of commercially available products, which can be helpful for scientific understanding of product function, for design verification, for market research and formulation of development goals of manufacturers. To respond to new demands of modern implants that are now emerging out of today‘s very reasonable safety and efficacy requirements, new innovative testing processes are being developed in close cooperation with our partners at the University of Rostock and our customers, which can then be offered as standardized tests.
Accredited testing methods
Our accreditation in accordance with DIN EN ISO/IEC 17025:2018 (from the German Accreditation Authority, DAkkS) and our recognition as a test laboratory for medical products in accordance with 93/42/EEC and DIN EN ISO/IEC 17025:2018 (by the central authority of the German Länder for health protection, ZLG) both confirm our competence and quality and identifies us as a reliable partner for industry and notified bodies. Within the Mutual Recognition Arrangement (MPA) DAkkS accreditation is recognized by all member states of the International Laboratory Accreditation Cooperation (ILAC) over the world. ► read more
Testing methods beyond the accredited range
Beyond the accredited testing range, the test laboratory offers further methods validated within by the QM system, which have proven to be successful especially in comparative investigations of newly developed products or products available on the market. ►read more