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Focus on your duties and leave us to worry about:

check-whiteCompliance with legislative requirements

check-whiteStaying up-to-date with the latest legislation

check-whiteImplementation in core activities and procedures

check-whiteInteraction with inspections and controls

Focus on your duties and leave us to worry about:

check-whiteCompliance with legislative requirements

check-whiteUp-to-date with the latest laws and legislations

check-whiteImplementation in core activities and procedures

check-whiteInteraction with inspections and controls

ISO 13485:2016
System for Medical Devices

ISO 13485:2016 defines requirements that organization must fullfill in order to produce medical devices and related services.

This standard applies to organizations which:

  • Are involved in production of medical devices in any phase of:
    • Production
    • Design
    • Development
    • Storage
    • Distribution
  • Instalation or maintenance of medical devices
  • Other similar activities related to follow-up services pertaining to medical devices.

ISO 13485:2016 can also be applied to suppliers who’s products and services are implemented in the products of the organization implementing ISO 13485.

Organization is responsible for the processes described in ISO 13485:2016, which are applicable to the organization, and are performed by other entities – those processes must be listed in the documentation.

Why hire Suport-TQM?

Consulting company with licenses and proffesionals with state license exams

Experience in large number of industries and many types of companies

Professional representatives with years of experience, oriented on practicality and efficiency in implementation

Reliable systems maintenance service

Well-oiled cooperation with licensed companies who’s services are required in order to complete legislative permits and documentation

In case of emergencies we are available 24-hours to start solving problematic issues within the inspections deadlines

For any questions you might have?Contact us