Medical Devices

At SQS, we work to help healthcare companies in an agile way.

We have over 15 years of experience in this sector. We help companies with both validation and verification tasks for medical software products, following the applicable regulations and standards, as well as advising on the implementation of quality processes.


  • Medical device validation and verification
  • Consulting services for medical device software certification
  • Consulting services for the implementation of a quality management system under ISO13485
  • Consulting services for the implementation of harmonized standards related to medical devices
  • Implementation of specific standards related to medical device software
  • Training for client personnel

Self-assessment tool for ISO 13485

This is a self-assessment tool for companies considering obtaining ISO 13485 certification. It is designed to highlight the key aspects that have the greatest impact on the application of the standard. This selection has been made with the aim of helping companies prioritize tasks and have a preliminary indication of the effort required.

Please note that the answers to the questions are not saved, so make sure to download or screenshot the results before closing the questionnaire window.

There are two options for viewing the score and task associated with each answered question:

  • The first view is organized by the sections in which the questionnaire questions are grouped.
  • The second view organizes the questions according to the chapters of the ISO 13485:2016 standard.

Contact an expert

If you want to know more about the subject or have any other question, do not hesitate, contact us.


ISO 9001

ISO/IEC 27001

ENS-nivel medio

ISO 20000


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