PROSYSTEM supports you with all the questions and tasks regarding quality management system in a worldwide manner. With our contribution at the ISO TC210/WG1 and years of experience, we define in cooperation with you an efficient and regulatory safe solution for your company.
PROSYSTEM assists you among others with the following topics:

  • ISO 13485:2003/EN ISO 13485:2012 – Quality management systems for manufacturers of medical devices
  • ISO 9001 – Requirements on a quality management system
  • FDA: 21 CFR 820 Quality System Regulation
  • ANVISA: RDC 16/2013
  • Preparation and support for FDA inspections and audits
  • Internal and supplier audits

Please feel free to contact us for further details about quality management systems or a nonbinding quotation.