Quality Management of em-tec GmbH

Our Quality Management System fulfills requirements from:

  • Medical Devices Directive 93/42/EEC
  • Directive 2014/30/EU on electromagnetic compatibility
  • Directive 2011/65/EU (RoHS II)
  • ISO 13485: 2012                                                                       (QM-System for medical products, certified by TÜV Süd)
  • 21 CFR Part 820 (US-FDA, Quality System Regulation)
  • Japan J-QMS Confirmation Letter
  • NRTL Surveillance (inspections by TÜV Süd)

Application Life Cycle Management Software Tool:

  • Tool „Polarion“ for support in development, verification and creation of documents


Click here to view the Certificate for ISO 13485: 2012

Click here to view the J-QMS Confirmation letter for Japan

Click here for checkmark reference