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Company » Quality Management

Quality Management

RAUMEDIC places customer satisfaction and compliance with all relevant legal and official requirements at the core of its quality principles. For this purpose we have introduced a comprehensive Quality Management System:

  • QM-System to ISO 13485:2003 and ISO 9001:2000
  • Quality assurance system to appendix II of EU regulation 93/42/EWG
  • Clean room production according to DIN EN ISO 14644, Class 7
    ( = 10.000)
  • Production conforming to GMP
  • Skilled technical support for CE-certification process





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