TÜV Rheinland Italy has awarded Bonebridge the CE certification in accordance with the MDR regulation for Class IIb implantable devices

As Notified Body No. 1936 for the CE marking of medical devices, TÜV Rheinland Italia has granted Bonebridge, a Swiss company dedicated to developing innovative solutions for fracture care, the certificate No. ITH 2477191 in compliance with Annex IX of the EU Regulation 2017/745. This certificate encompasses critical Class IIb devices, specifically designed for surgical procedures in the field of osteosynthesis.

The certification process meticulously addressed the complexities associated with long-term implantable devices. Surgeon specialists in orthopedics and osteosynthesis closely collaborated with the team of technical experts at TÜV Rheinland Italia, ensuring that every aspect of the production process and material characteristics meet high standards of safety and functionality.

TÜV Rheinland Italia's commitment to ensuring a thorough and detailed CE Certification path for implantable products exemplifies its mission: to ensure that every medical device meets the requirements for clinical safety in an ever-evolving sector. TÜV Rheinland Italia's ability to blend technical expertise with specific knowledge of the materials used for long-term invasiveness and surgical techniques, also thanks to collaboration with specialized doctors, underlines its professional nature, marked by competence and seriousness.

For Bonebridge, obtaining certification in accordance with the MDR means that the company complies with one of the most advanced regulations in the industry and is committed to offering safe, state-of-the-art medical devices. It also demonstrates that Bonebridge's orthopedic implant systems are the result of meticulous and dedicated work in research, development, and design.

TÜV Rheinland Italia continues to demonstrate its value as a benchmark in the sector, significantly contributing to both the medical community's progress and technological advancement in the industrial field, in the context of transitioning to the new EU Regulation 2017/745.

As a Notified Body No. 1936 for the CE marking of medical devices, TÜV Rheinland Italia has granted Bonebridge, a Swiss company dedicated to developing innovative solutions for fracture care, the certificate No. ITH 2477191 in compliance with Annex IX of the EU Regulation 2017/745. This certificate encompasses critical Class IIb devices, specifically designed for surgical procedures in the field of osteosynthesis.

For Bonebridge, obtaining certification in accordance with the MDR means that the company complies with one of the most advanced regulations in the industry and is committed to offering safe, state-of-the-art medical devices. TÜV Rheinland Italia continues to demonstrate its value as a benchmark in the sector, significantly contributing to both the medical community's progress and technological advancement in the industrial field, in the context of transitioning to the new EU Regulation 2017/745.TÜV Rheinland Italia continua a dimostrare il proprio valore come punto di riferimento nel settore, contribuendo in maniera significativa sia al progresso della comunità medica che all'avanzamento tecnologico nel settore industriale, nel contesto della transizione al nuovo Regolamento UE 2017/745.