Sculpteo achieves ISO 13485 certification

Sculpteo, an online 3D printing service provider, has been awarded ISO 13485 certification by the Association Française de Normalisation (AFNOR). This certification underscores Sculpteo’s commitment to excellence in medical device manufacturing and covers a broad range of medical products. By achieving this milestone, Sculpteo strengthens its presence in the healthcare sector – aligning with the industry’s most stringent standards to deliver customized medical devices that are more comfortable and compatible with patients’ bodies.

ISO 13485 sets the criteria for a quality management system specifically for medical devices – ensuring full traceability of all operations and stringent control over changes in manufacturing processes. Medical devices are categorized into different classes based on their associated risk levels, ranging from Class I (lowest risk) to Class III (highest risk), with Sculpteo’s certification encompassing Class I and IIa medical devices:

• Class I: Prosthesis covers, corrective eyeglasses, vehicles for disabled people, and crutches, among others.
• Class IIa: Certain prosthesis fittings, contact lenses, ultrasound equipment, and dental crowns.
• Class IIb: Higher-risk items such as condoms and contact lens disinfectants.
• Class III: The highest-risk items such as breast implants, stents, and hip prostheses.

By focusing on Class I and IIa products, Sculpteo positions itself as an expert in manufacturing prostheses, orthoses, and plagiocephaly helmets.

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

“This new certification confirms the role of Sculpteo and 3D printing in industrial manufacturing, this time in the highly demanding world of medical devices. Together with our partners, we can now envision manufacturing healthcare devices that are more comfortable, effective, and aesthetically pleasing,” said Alexandre d’Orsetti, CEO of Sculpteo.

Sculpteo’s process for producing medical devices involves several critical steps:

1. Identification of appropriate materials for each application.
2. Selection of materials to ensure durability, biocompatibility, and regulatory compliance.
3. Rigorous testing to validate material and device compliance with industry standards.
4. Maintain complete documentation throughout the project, including design records, material batch numbers, and manufacturing specifications.
5. Defining its own specifications for medical devices, and adapting to specific customer requirements on request.
6. Production of Class I and IIa medical devices.

Through these meticulous processes, Sculpteo produces Class I and IIa medical devices that meet the highest standards of quality and safety.