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.

 

Product Certifications

  • GasN2 is certified by the AEMPS (Spanish Agency of Medicines and Medical Devices) under notified body ON0318, in accordance with the UNE-EN ISO 13485:2018 standard, including EN ISO 13485:2016 and ISO 13485:2016).
  • GasN2 is certified in accordance with ISO 9001:2015, which guarantees a quality management system focused on continuous improvement and customer satisfaction.
  • Our equipment complies with the strictest health and safety standards, guaranteed by the CE marking for medical devices, in accordance with EU Regulation 2017/745.
  • They are in full compliance with the European Pharmacopoeia, 11th Edition, ensuring the highest quality for the 93% medicinal oxygen produced by our devices.

 

Corporate and Sustainability Certifications

  • GasN2 is certified as a B Corp company, demonstrating our commitment to the highest standards of social, governance, and environmental performance, transparency, and corporate responsibility.
  • Our Barcelona office holds LEED Platinum certification, the highest international category in sustainable building, recognizing the energy efficiency, responsible use of resources, and environmental quality of our facilities.