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Production and Quality Management

Meeting regulatory and customer needs is our focus.

Production

Production Facility in Munich, Germany

  • 400 m² high technology manufacturing site
  • Continual optimisation: in 2005 Lean Management was pioneered to drive change and to cut waste in the processes

High quality standards are achieved with a 100 % in-process control by visual cameras in various steps designed to meet customer and regulatory needs.

Production in Pistoia, Italy

The leading manufacturer for endodontic motors in the world.

  • Manufacturing site with 5 assembly lines for kitting and equipments, incl. testing and packing.
  • Laser machine for metal and plastic engraving/marking.
  • Tampon printing equipments for plastic.
  • Manufacturing area: ~ 230 m2
  • Warehouse area: ~ 200 m2
  • Quality System: Certified against ISO 13485, MDD 93/42/CEE and FDA.

Quality management

VDW is Certified manufacturer of medical devices according to 93/42/EEC

  • Compliance with Medical Device Directive 93/42/EEC/Revised Directive/2007/47/EC
  • Compliance with MPG: German national law for medical devices
  • Certified according to ISO 13485:2003
  • Certified according to CMDCAS - quality management according to Canadian Medical Device Regulation SOR 98-202 seit July 2009
  • Compliance with USA Regulations for Medical Devices FDA 21 CFR 820
  • Implementation of Japanese Pharmaceutical Administration and Regulations / PMD Act since 25 November 2014
  • EC Certification for the European Union
  • Worldwide registration of our medical devices and products including in USA, Canada, China, Japan, Russia, Central and South America
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