3D printing specialist Sculpteo receives medical ISO 13485 certification

3D printing specialist Sculpteo has announced the achievement of ISO 13485 certification, awarded by the Association Française de Normalisation (AFNOR). This certification underlines Sculpteo’s commitment to quality and safety in the medical field and marks a significant step forward in its capabilities and commitment to the healthcare industry.

The process to achieve ISO 13485 certification involves identifying appropriate materials for each application to ensure durability, biocompatibility and regulatory compliance. Sculpteo conducts rigorous testing to validate material and device compliance with industry standards and maintains complete documentation throughout the project.

Sculpteo’s CEO, Alexandre d’Orsetti, highlights the importance of this achievement: “This new certification confirms Sculpteo’s role in industrial manufacturing, particularly in the demanding field of medical devices. Together with our partners, we can now envision producing healthcare devices that are effective, comfortable, and aesthetically pleasing.”

Sculpteo’s ability to manufacture Class I and IIa components for medical devices positions it as an expert in innovative solutions such as prostheses, orthoses and helmets for the treatment of plagiocephaly. These products are designed to meet the specific needs of patients and improve their comfort and quality of life.

Luc Boronat, CEO of Qwadra, a key partner of Sculpteo, adds: “At Qwadra, we are delighted to celebrate our partner Sculpteo’s achievement of the prestigious ISO 13485 certification. This strengthens our mutual trust and solidifies our partnership. We are convinced that through this qualification, we can offer our customers orthopedic devices of impeccable quality, ensuring their well-being and satisfaction.”

Sculpteo’s ISO 13485 certification marks a significant step forward in the company’s mission to provide high quality and innovative components for medical devices. This strengthens Sculpteo’s position at the forefront of the 3D printing industry and demonstrates the company’s commitment to excellence in medical device manufacturing.