Understanding of Quality and Compliance With Regulations – RAUMEDIC Offers You Qualified Support

Certified Quality Management

Customer satisfaction and compliance with all relevant legal, normative and regulatory requirements are the focus of our concept of quality. In order to meet these requirements, RAUMEDIC has established a comprehensive certified quality management system:

  • QM system according to ISO 13485 and ISO 9001
  • Complete quality assurance system according to EC Directive 93/42/EEC 
  • Complete quality assurance system according to EC Directive 90/385/EEC

RAUMEDIC Manufacturing in a Controlled Environment

Manufacture processes such as the production of medical products or semi-finished medical products as well as pharmaceutical products place high demands on the environmental conditions. RAUMEDIC therefore manufactures in a controlled environment:

  • Clean room manufacturing according to ISO 14644, ISO Class 7 (=10,000)
  • GMP orientated manufacturing

CE Marking for the European Economic Area

The CE declaration of conformity and the CE marking are necessary for marketing within the European economic area. CE conformity assessment procedures for RAUMEDIC medical products in line with:

  • Appendix II of EU Directive 93/42/EEC
  • Appendix 2 of EU Directive 90/385/EEC

As part of custom developments, we provide support for CE certification processes.