Sculpteo Achieves ISO 13485 Certification: A Major Milestone in the Medical Industry

Posted By Stephany Vaussanvin on May 29, 2024 | 0 comments

Sculpteo, a leader in 3D printing, has proudly announced its attainment of the ISO 13485 certification, awarded by the Association Française de Normalisation (AFNOR). This prestigious certification underscores Sculpteo’s commitment to quality and safety in the medical sector, marking a significant advancement in its capabilities and dedication to the healthcare industry.

ISO 13485 is a globally recognized standard for quality management systems specific to medical devices. It mandates stringent criteria for ensuring the highest levels of traceability and control throughout the manufacturing process. Sculpteo’s certification covers Class I and Class IIa medical devices, including prosthesis covers, corrective eyeglasses, specific prosthesis fittings, and dental crowns.

Commitment to Innovation and Quality

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.”

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.”

A Step Forward in Medical Device Manufacturing

The ISO 13485 certification process involves identifying appropriate materials for each application, ensuring 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 ability to manufacture Class I and IIa components for medical devices positions it as an expert in creating innovative solutions such as prostheses, orthoses, and plagiocephaly helmets. These products are designed to meet patients’ specific needs, enhancing their comfort and quality of life.

Sculpteo’s ISO 13485 certification marks a significant leap forward in its mission to deliver high-quality, innovative components for medical devices, reinforcing its position at the forefront of the 3D printing industry.

About Sculpteo

At Sculpteo, we are pioneers in digital manufacturing and leaders in 3D printing technology. Since our founding in 2009, we’ve been dedicated to providing innovative and high-quality solutions to businesses and individuals worldwide. With our easy-to-use online platform, you can securely upload your 3D files, choose from over 75 materials and finishes, and let our professional engineers bring your designs to life using cutting-edge 3D printing technologies. Wherever you are on your 3D printing journey, you can count on us as your dependable innovation partner.

Let’s create something amazing together! Contact us today!