BMT’s quality philosophy is supported by exacting inline inspection protocols implemented by either the quality management team or the production workers themselves.
At the end of the production line, we perform a 100% non-destructive inspection as well as a comprehensive range of destructive tests on a specific number of devices. All these efforts result in high quality products, satisfied customers, and patients whose expectations of a safe and successful treatment are fully met.
BMT is certified according to DIN EN ISO 13485. Most of our standard catheters are CE certified. BMT also owns the official manufacturing license in accordance with the German pharmaceutical law (AMG) for the drug-coating of balloons.
As a special service, we offer all the necessary support for our customers to achieve local approval in any part of the world.
Furthermore, our contract development services are performed according to the European regulations as well as the FDA regulations if required.
"For a dynamic quality system that maintains the highest globally accepted standards, the whole team must be fully dedicated and committed to quality."