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QA and Regulatory Management

S4MDC offers a variety of services to the industry providing knowledge and business solving solutions to manufacturers with respect to international regulations.

  • Quality certification ISO 9001, ISO 13485, ISO 14001 and safety management system specification OHSAS.
  • Advice for CE marking medical devices and IVD.
  • Verification of software standards according to IEC 62304.
  • Data bank recording of medical devices.
  • Consultancy for recording of medical devices in Europe, Canada and USA.
  • Advisory services for non EU countries and European Legal Representative Services and management of regulatory aspects according to European directives.
  • Support for clinical evaluations through qualified medical staff.
  • Planning and performing training activities in the QA field, workplace safety and CE mark.
  • Support for regional and state funding activities.
  • Authorized Representative Service capability