ISO 13485 Certification Granted to Sculpteo

Online 3D printing service provider Sculpteo has achieved ISO 13485 certification, an accomplishment that will help support the company’s efforts to inccrease its healthcare sector presence. Awarded by the Association Française de Normalisation (AFNOR), the certification covers class I and class IIa medical products.  

ISO 13485 defines the requirements for a quality control system applied to medical devices. It imposes strict criteria established by the certifying body, ensuring full traceability of all operations and control of changes in manufacturing processes. “This new certification confirms the role of Sculpteo and 3D printing in industrial manufacturing, this time in the highly demanding world of medical devices,” Sculpteo CEO Alexandre d’Orsetti said. “Together with our partners, we can now envision manufacturing healthcare devices that are more comfortable, effective and aesthetically pleasing.”

With class I and class IIa products, Sculpteo is attempting to position itself as an expert manufacturer of prostheses, orthoses, and plagiocephaly helmets. The company’s manufacturing process involves material identification and selection to ensure durability, biocompatibility and regulatory compliance. Rigorous testing is then performed to validate material and device compliance with industry standards. Sculpteo maintains complete documentation throughout the project, including design records, material batch numbers and manufacturing specifications. The company also defines its own specifications for medical devices, and adapts to specific customer requirements on request.

Company bigwigs say the ISO 13485 certification marks a significant step forward in Sculpteo’s commitment to innovation, quality and the safety of medical products.

“We are delighted to celebrate our partner Sculpteo’s achievement of ISO 13485 certification,” Qwadra CEO Luc Boronat stated. “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.”

Sculpteo, a pioneer and specialist in digital manufacturing, offers an online 3D printing service. Sculpteo provides an online platform to securely upload 3D files and select from more than 75 materials and finishing options. Professional engineers and technicians produce parts on industrial 3D printing technologies before sending them to businesses and individuals worldwide. Based in Paris and San Francisco, Sculpteo offers on-demand 3D printing and manufacturing at a large scale for startups, small and medium enterprises, and design studios. Sculpteo offers its professional 3D printing service alongside its expert Design Studio to help businesses integrate additive manufacturing into their product development and production systems. Sculpteo was founded in 2009 by Eric Carreel and Clément Moreau and is led by d’Orsetti, former director of Sculpteo’s design studio. BASF New Business GmbH acquired the company in November 2019.

BASF 3D Printing Solutions GmbH, headquartered in Heidelberg, Germany, is a subsidiary of BASF New Business GmbH. It focuses on establishing and expanding the business under the Forward AM brand with advanced materials, system solutions, components, and services in 3D printing. BASF 3D Printing Solutions is organized into startup-like structures to serve customers in the 3D printing market. It cooperates closely with the global research platforms and application technologies of various departments at BASF and research institutes, universities, startups, and industrial partners. Potential customers are primarily companies that intend to use 3D printing for industrial manufacturing.