Biegler GmbH

Profile

  • RDM* medical devices
  • Founded in: 1973
  • Staff: 40
  • Focus: Anaesthetic and respiratory devices, Dental devices
  • Cluster Membership: MedTech-Cluster, ecoplus
  • Profile: Biegler has been successfully involved in development and production of medical devices and disposables for more than 40 years. In addition Biegler offers the integrated development and productionof medical products as OEM Services. Biegler is FDA registered for several products. Certification: ISO 13485: 2003, CE 0123
  • R&D: Research and development is one of the core competences at Biegler. The company covers the entire spectrum, from initial concept through to implementation in serial production. Biegler places great value on combining the knowledge of their customers with their own expertise as early as possible, to enable the speediest possible realization of projects.
  • Production: The product range of Biegler can complete all mechanical production stages, from prototype production (design models) through to series production. Metal working is in state-of-the-art CNC lathes and milling machines and the company can also work on in-house sheet metal working facilities (e.g. hydraulic presses, folding equipment). The tooling production facility enables Biegler to manufacture the equipment required for automation themselves. In addition, there are also facilities for plastic injection molding and the own mold shop. Assembling and packaging of medical disposables can be done in its own cleanroom.
  • Services: Biegler does not offer just the technical but all the regulatory prerequisites for succesful partnership with OEMs. Biegler has been EN ISO 9001 and EN 46001 certified since 1994, and became EN ISO 13485:2003-certified in 2003. The company can provide the documentation required for receiving the CE Mark and also undertake the entire CE Mark certification process.
  • Sales/Distribution: Biegler has a worldwide distributor network for its own products, the sales of the OEM products is performed worldwide by the respective partner.

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