Certificates and Quality
Certifications that reinforce trust
At Mediflex, quality is not just a promise. It is the result of controlled processes, carefully selected raw materials, and a culture of rigor applied at every stage.
We work in an industry where every detail matters. That's why Mediflex products are developed responsibly, according to recognized standards and with a focus on safety, comfort, and long-term performance.
Our certifications reinforce Mediflex's commitment to quality, traceability, safety, and continuous improvement.
ISO 13485 - ISO 13485 is an international standard specifically for quality management systems applied to medical devices.
In practice, this means that Mediflex works with controlled processes, proper documentation, traceability, and an approach focused on the safety and compliance of hospital products.
This certification is especially important because Mediflex products are developed for healthcare settings where reliability, consistency, and control are essential.
Management system certifications
Mediflex benefits from the certified structure of Flex2000, which integrates recognized benchmarks in the areas of quality, environment, safety, occupational health and innovation.
ISO 9001 - Quality management system.
Reinforces the commitment to consistent processes, continuous improvement, and customer satisfaction.
ISO 14001 - Environmental management system.
Demonstrates a responsible approach to environmental management and reducing the impact of industrial activity.
ISO 45001 - Occupational health and safety management system.
Reflects the commitment to safer work environments and the protection of people involved in the processes.
ISO 56001 - Innovation management system.
Strengthens the ability to develop, improve and adapt solutions to market and user needs.
IATF 16949:2016 - Recognized certification in the automotive industry, validating the excellence of our quality management system.
Product certifications and compliance
In addition to management systems, Mediflex products integrate materials and components evaluated according to recognized standards.
CE Marking - Class I Medical Device - Some Mediflex products have CE marking as a Class I Medical Device, in accordance with European Regulation EU 745/2017.
This conformity indicates that the product meets the applicable requirements to be placed on the European market as a medical device.
OEKO-TEX® Standard 100 - The OEKO-TEX® Standard 100 assesses the presence of harmful substances in textile materials.
In Mediflex products, it can be applied to the core and/or the sheath, contributing to greater confidence in the safety of the materials used.
Safety, hygiene and performance
Mediflex products are developed with attention to the real demands of daily care.
Depending on the product, they may include waterproof, breathable and washable covers, ultrasonically welded seams, protected zippers, antibacterial treatment and materials designed to facilitate cleaning, reduce leaks and contribute to hygiene in clinical, hospital or home environments.
The choice of materials, the construction of products, and the control of technical characteristics are an essential part of Mediflex's commitment: to offer comfortable, safe, and reliable solutions for both caregivers and those being cared for.
Our commitment
At Mediflex, certification is more than just meeting requirements.
It's about ensuring that each product is developed with seriousness, produced with rigor, and delivered with the responsibility that the care context demands.
Because when we talk about health, comfort, and safety, trust has to be present in every detail.
