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Management system guaranteeing quality: ISO 13485 and ISO 9001

The implementation of a quality system is an added value for companies and a guarantee of quality for their clients.


The international standard ISO 13485 is the reference standard for the management quality system, specific for companies that operate in the medical sector. The standard specifies the requisites for the system of management of the quality of the organizations that operate both in design and production of medical devices, as well as of the design and supply of correlated services.

Our specialized team have the recognized specific knowledge of ISO 9001 and ISO 13485, and are able to support companies in the implementation of:

  • Quality systems, also in the request for certification,
  • Manual of quality system and relative SOP,
    • Risk management plan (RMP),
    • Management of the relationship with the Certified Bodies,
    • Assistance during audits.

Moreover, we also provide the quality responsible person in outsourcing.