Certifications

We strongly believe that commitment and hard work should be measurable.

That’s why we have a quality management system that allows us to monitor our progress and make continuous improvements. It enables us to control and maintain efficiency in our production process and at the same time sets the guidelines to meet the standards and regulatory requirements that apply to our sector.

All our production processes are governed by work regulations and quality controls that allow us to have finished products of the highest quality, in compliance with the applicable legislation.

All our GO Top Line Health medical devices deliver the highest quality and safety, meeting the most demanding standards.

Specifically:

  • Certified by the AEMPS (Spanish Agency of Medicines and Medical Devices) under the notified body ON0318, in compliance with the UNE-EN ISO 13485:2018 standard (including EN ISO 13485:2016 and ISO 13485:2016).
  • Meet the strictest health and safety standards, guaranteed by the CE marking for medical devices, in accordance with Directive 93/42/EEC (valid until 2021).
  • Fully compliant with the 11th Edition of the European Pharmacopoeia, ensuring the highest quality of medical oxygen used in our devices.

These certifications reflect our commitment to excellence, safety, and reliability in the medical field.