Quality at the heart of Thuasne’s commitment®
Health solutions recognized by the authorities
Thuasne® designs, develops, manufactures and distributes non-invasive medical devices in the fields of orthopedics, medical compression and sports.
A medical device is a healthcare product for use in the diagnosis, prevention, control, treatment or alleviation of disease or injury. Its principal intended action in or on the human body is not achieved by pharmacological or immunological means or by metabolism, but its function can be assisted by such means(1).
These healthcare solutions meet regulatory requirements defined by EU Regulation 2017/745, relating to medical devices, that came into force on May 26, 2021.
A demanding and certified quality policy
Thuasne® places patient health and safety at the heart of its strategy. This ambition is reflected in the marketing of medical devices that comply with the most stringent regulations and standards.
Compliance with EU Regulation 2017/745 and ISO 13485: 2016 certification are the result of a strict and documented quality and regulatory approach, incorporating regular audits to maintain ever higher standards.
Regulations and certifications
EU Regulation 2017/745
Among other things, the EU Medical Devices Regulation imposes new requirements in terms of traceability, safety and clinical effectiveness. Thuasne® has integrated these obligations into its processes, demonstrating its expertise and reliability.
CE marking
In line with European regulation EU 2017/745, the marketing of a medical device is conditional on obtaining CE marking, prior to its commercialization. It certifies that the medical device complies with the safety and performance requirements set out in European legislation.
ISO 13485
Thuasne®'s European and American production sites are ISO 13485:2016 certified. This certification guarantees the quality and regulatory compliance of medical devices throughout their life cycle. Complementary to the other requirements, it is essential for maintaining the CE marking of Thuasne® products.
Made in Thuasne® : total process control
Thuasne®'s commitment to quality is directly linked to its unique industrial model: control from design to marketing. This integrated approach guarantees rigorous traceability and rapid adaptation to the needs of patients and healthcare professionals.
Thuasne® applies high quality standards to class 1 medical devices. Any changes in processes or solution components are evaluated to measure their impact and ensure the efficiency and safety of the finished product. The Group also relies on cutting-edge technologies, such as automated digital vision control.
Thanks to this control of the entire value chain, Thuasne® offers medical devices that comply with regulatory requirements.
Quality and sustainability: a key synergy
Thuasne® places sustainability at the heart of its processes. The use of Oeko-Tex® certified textiles embodies this commitment to effective, environmentally-friendly healthcare solutions. The Oeko-Tex® Standard 100 label guarantees the absence of harmful substances in textiles, thanks to strict controls carried out by independent laboratories. Thuasne® has obtained this certification for the Venoflex Kokoon Absolu, Lymphatrex Revolution and Panty Mobiderm Intimate ranges.
This initiative is part of a broader eco-design and responsible purchasing approach aimed at limiting the environmental impact of solutions. By rigorously selecting raw materials and optimizing its manufacturing processes, Thuasne® reinforces its commitment to a safe and sustainable textile industry.
