Bavaria Medizin Technologie GmbH (BMT) specialises in designing, developing, and manufacturing medical devices.
The company’s focuses on catheters, which are used for many different medical applications, from non-vascular ear, nose and throat (ENT) treatments; to the dilatation of arteries; as delivery devices for stents; for drugs or heart valves; and for injection of stem cells into the myocardium.
With more than 25 years’ experience, BMT’s company motto ‘We Know How’ is already well-known in the market and is constantly reflected in the company’s ever-growing global clientele.
Full turnkey or standalone services from early stage R&D to high-volume manufacturing
BMT performs research and development (R&D) and customised device manufacturing either as a full turnkey solution or as a standalone service.
Tasks are performed quickly and efficiently. The company also provides external services to customers such as biocompatibility testing, accelerated ageing, or pre-clinical testing of devices in animal models. Performed by external partners, these services complete the turnkey solution and make BMT a one-stop-shop for medical devices.
If a customer only requires some services, and not a full package, these can also be ordered as a standalone service, which can be for instance a benchmark testing of a device or the proof of a certain product concept.
Packaging design and development, crimping and testing of stents
The company offers design and development of product packaging, which pass sterilisation requirements and transportation simulation.
Other services available include the crimping of stents onto balloons. BMT has various methods, depending on the stent material and whether it is a drug eluting stent or not. Besides the crimping, BMT also tests the retention force of the stent on the balloon, as well as expansion behavior.
Pioneer in drug coated balloons
BMT is a pioneer in the development of drug coated balloons (DCB) for coronary and peripheral applications. Its specific clean rooms meet good manufacturing practice (GMP) requirements and the company has an official manufacturing license from the competent authority to handle cytotoxic agents.
Development of coating machines and coating processes
The company develops drug coating machines for dilatation balloons and processes according to customers’ needs. BMT also handles the required analytical testing regarding drugs and excipients for the coating formulation and for the finished device, but these tests are carried out at external labs.
Regulatory approval of medical devices and OEM/PLM procedures
As a medical device developer and manufacturer, BMT is certified according to ISO 13485. It also meets regulatory requirements of the ministries of Health, Labour, and Welfare in Japan and the US.
BMT´s quality management system is up-to-date and regularly audited by the company’s notified body and customers. Besides BMT´s own CE approved devices, its regulatory affairs team also assists customers in device approval. This can be as part of an original equipment manufacturer (OEM) / private label manufacturing (PLM) procedure based on BMT´s devices, but also at the end of the device development phase when the design dossier is finalised for the submission to the customer´s notified body. Even if customers are seeking local device approvals in specific countries, BMT offers full support in creating protocols, reports, or other documents, which are required from customers respectively from the local authorities.
About BMT
BMT is located in Wessling, which is West of Munich, Germany. BMT´s devices and processes are characterised by German engineering, with a very high degree of quality and reliability.
Since 2008, BMT has established a second manufacturing site in Sibiu, Romania, which is also certified according to ISO 13485. With these two manufacturing sites, the company’s production capabilities are very flexible and it is able to manufacture pilot runs and very high volume devices.
So if your requirement is quality, choose BMT: Your partner from concept to market.
Details about BMT’s expertise and services can be found on the Products & Services tab.
