Medical devices – regulatory & GMP

Medical devices  regulatory advice & support

  • Coming at you like an express train..
    • Medical Devices Single Audit Programme (MDSAP),
      • Taking over from Canadian CMDCAS by end 2018
    • European Medical Devices Regulations (MDRs effective 2020 – CE Marks expire…)
    • Changes in ISO 13485:2016
  • There right now…
    • Canadian SOR-98-282 Medical Device Regulations with  CMDCAS &  ISO 13485:2003
    • CE Marking
      • EU Medical Device Directives (Articles and Annexes)
      • MEDDEVs
    • US FDA inc GMP as per 21CFR-820
    • Japan Ord 169
    • Taiwan FDA
    • Korea MFDS
  • Medical devices regulatory surveillance
    • Get a monthly report vs your product codings…

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