We have been assessed and certified as meeting the requirements of the latest ISO 13485:2016 quality certificate. The certificate involves all products and services of Mediconsult and it was admitted by SGS Fimko Oy.
ISO 13485 (Medical devices) is an internationally acknowledged quality system standard, which guides the operations of companies participating in the supply chain and lifecycle of healthcare appliances and devices.
ISO 13485:2016 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organizations can be involved in one or more stages of the life-cycle, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).
The ISO standard is also a prerequisite for the upcoming European Medical Device Regulation (MDR) certificate.