Certifications

Commitment to Quality and Excellence

We have implemented a quality management system that helps us continuously monitor our progress and promote constant improvement. This system ensures efficiency at every stage of our production process while guaranteeing compliance with the applicable standards and regulatory requirements in our sector.

All our production processes are subject to strict work standards and quality controls, enabling us to deliver finished products of the highest quality, fully aligned with current legislation and our clients’ expectations.

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

  • 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.