VDW Quality Management

Quality Management System

  • 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

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

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