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Is ISO 13485 certification required to service providers (not into manufacturing) of Medical Devices



  • Sridhar Sarva
    23/06/2020 13:41
    Hi, We are service providers to Medical Device industry and are not directly involved in Manufacture of medical devices. We are ISO 9001:2015 certified. Some customers are asking if we are ISO 13485 certified. Please help me understand if we need to get ISO 13485 certification given the fact we are just providing regulatory service to Medical Device manufacturers
  • Albert
    29/07/2020 14:37
    Iso Certification is required. but its is must to get CEO Marking Certification http://iasiso-asia.com/PH/ce-marking-certification-in-philippines
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