Certifications

ScanMed and its employees hold multiple MRI-industry certifications. We continuously remain educated on industry changes and standards and our certifications validate our knowledge and expertise of MRI coils.

  • ISO Certified for RF coil repair
  • ISO 9001:2008 – Quality Management Systems – Requirements
  • ISO 13485:2003 – Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes
  • ISO 14971:2000 – Medical Devices – Application of Risk Management to Medical Devices
  • ISO 10993-1:2003 – Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing IEC 60601-1 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
  • IEC 60601-2-33 – Medical Electrical Equipment – MRI
  • 21CFR820 – FDA Medical Device Quality System Regulation
  • MDD93/42/EEC – Council Directive Concerning Medical Devices
  • SOR/98-282 – Canada Medical Devices Regulations
  • NEMA MS-6 – Characterization of Special Purpose Coils for Diagnostic Magnetic Resonance Images
  • NEMA MS-8 – Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
  • UL94 – Test for Flammability of Plastic Materials for Parts in Devices and Appliances
  • UL544 – UL Standard for Safety Medical and Dental Equipment Canadian Medical Device License number 72002