Sculpteo obtains ISO 13485 certification

Sculpteo, an online 3D printing service provider, has received ISO 13485 certification from the Association Française de Normalization (AFNOR). This certification highlights Sculpteo’s commitment to excellence in medical device manufacturing and covers a wide range of medical products. By achieving this milestone, Sculpteo is strengthening its presence in the healthcare sector – aligning with the most stringent industry standards to deliver personalized medical devices that are more comfortable and compatible with patients’ bodies.

ISO 13485 establishes criteria for a quality management system specifically for medical devices – ensuring full traceability of all operations and strict control of changes in production processes. Medical devices are divided into different classes based on their associated risk levels, from Class I (lowest risk) to Class III (highest risk), with Sculpteo certification covering Class I and IIa medical devices:

• Class I: incl. denture covers, prescription glasses, disabled vehicles and crutches.
• Class IIa: certain denture components, contact lenses, ultrasonic equipment and dental crowns.
• Class IIb: Higher risk items such as condoms and contact lens disinfectants.
• Class III: Highest risk items such as breast implants, stents and hip replacements.

By focusing on class I and IIa products, Sculpteo positions itself as an expert in the production of plagiocephalic prostheses, orthoses and helmets.

“At Qwadra, we are happy to celebrate our partner Sculpteo achieving the prestigious ISO 13485 certification. This achievement reinforces our mutual trust and strengthens our partnership. Thanks to this qualification, we are convinced that we can offer our customers orthopedic products 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 production, this time in the very demanding world of medical devices. Together with our partners, we can now imagine producing medical devices that are more comfortable, effective and aesthetic,” said Alexandre d’Orsetti, CEO of Sculpteo.

The production process of Sculpteo medical devices includes several key stages:

1. Identifying the right materials for each application.
2. Material selection ensuring durability, biocompatibility and regulatory compliance.
3. Rigorous testing to ensure materials and equipment comply with industry standards.
4. Maintain complete documentation throughout the life of the project, including design records, material lot numbers and manufacturing specifications.
5. Defining your own specifications for medical devices and adapting to specific customer requirements upon request.
6. Production of class I and IIa medical devices.

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