ISO 13485:2016 - Quality Management System


We support your company in developing and implementing a Quality Management System (QMS) based on the requirements of the international standard ISO 13485:2016.

ISO 13485:2016 specifies requirements for a quality management system that can be used by an organization involved in one or more stages of the life-cycle of a medical device, including design and development, production, storage and distribution, installation, servicing and final decommissioning and disposal of medical devices.

According to this international standard, a medical device is for example an instrument, an apparatus, an implement, a machine, an implant, a reagent for in vitro use, software or other similar or related article, intended by the manufacturer to be used, alone or in combination, for human beings, for one or more of the specific medical purposes of:

  • Diagnosis, prevention, monitoring, treatment or alleviation of disease;

  • Diagnosis, monitoring, treatment, alleviation of or compensation for an injury;

  • Supporting or sustaining life;

  • Control of conception;

  • Disinfection of medical devices etc.

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