We are pleased to announce that GasN2 has obtained the prestigious UNE-EN ISO 13485:2018 certification (EN ISO 13485:2016 & ISO 13485:2016) under the regulation “Medical Devices – Quality Management Systems – Requirements for Regulatory Purposes.”
A Milestone That Reaffirms Our Commitment
This recognition validates our processes for the design, development, and production of medical gas supply systems and their components, solidifying our position in the market as a benchmark in quality, safety, and innovation.
This certification is particularly significant for our line of 93% oxygen generators for medical use, ensuring that we meet the strictest standards in the healthcare sector.
What Does UNE-EN ISO 13485:2018 Certification Represent?
The UNE-EN ISO 13485:2018 standard is an international benchmark that evaluates quality management systems specific to medical devices. This certification ensures that our processes and products comply with the most stringent legal and regulatory requirements in the medical sector.
Key Benefits of This Certification for Our Clients
- Certified by Competent Authorities: Our GO TOP Line Health generators are certified by the Spanish Agency of Medicines and Medical Devices (Notified Body ON318 and UNE-EN ISO 13485:2018). This guarantees the reliability and safety of our equipment.
- Compliance with the Highest Standards: Our generators meet the requirements of the Medical Devices Directive 93/42/EEC, with CE marking that ensures compliance with current health and safety regulations since 2021. We are also undergoing evaluation to comply with the new Medical Device Regulation 2017/745.
- Conformity with European Pharmacopoeia 11: This standard ensures the highest quality of medical-grade oxygen produced by our generators, guaranteeing compliance with requirements for medical use.
Why Is This Certification Important?
The UNE-EN ISO 13485:2018 certification positions us as leaders in the medical oxygen generator industry, standing out for our quality and reliability. This accreditation is not only a guarantee of quality but also a demonstration of our commitment to patients, healthcare professionals, and medical facilities that rely on our equipment.
What Is Our Goal?
With this new achievement, our primary goal is to continue developing innovative and efficient solutions that contribute to improving the quality of life of users and providing robust support to the healthcare sector.
At GasN2, we work every day to deliver technical excellence, reliability, and a personalized service tailored to the specific needs of each client.
This certification is just the beginning of a journey full of new challenges and innovations to continue making a difference in the healthcare sector.
