Sculpteo obtains ISO 13485 certification for the production of medical devices

Sculpteo, a leader in 3D printing, has received ISO 13485 certification from the Association Française de Normalization (AFNOR) for excellence in medical device manufacturing. This milestone enables the company to strengthen its presence in the healthcare sector with customized and patient-friendly medical products.

ISO 13485 establishes stringent criteria for quality control systems used in medical devices, ensuring full traceability and control of production processes. The certification covers various classes of medical devices, each with a specific risk level from class I to class III.

ISO 13485 classes

Class I	Class IIa	Class IIb	Class III
Lowest risk class	Moderate/measured risk potential	High/significant risk potential	The highest risk class
Prosthetic covers, corrective glasses, vehicles for disabled people, crutches	Some prosthetic fittings, contact lenses, ultrasound equipment, dental crowns	Condoms and contact disinfectants	Breast implants, stents, hip dentures,

French company Sculpteo, which provides on-demand 3D printing for startups and SMEs, covers classes I and IIa. Founded in 2009 by Eric Carreel and Clément Moreau, the company was acquired by BASF New Business GmbH in 2019 and is currently led by Alexandre d’Orsetti.

MedicalExpo electronic magazine reached out to Alexandre d’Orsetti, CEO of Sculpteo, to learn more about the results of the new certification, what it means for Sculpteo in terms of market expansion and partnerships, and how the company plans to work with healthcare professionals.

What products are covered by this certificate?

Alexandre d’Orsetti: “Sculpteo’s ISO 13485 certification covers a range of 3D printed medical components designed to meet the highest quality and safety standards. These products include surgical guides and instrumentation, orthopedic parts such as braces or helmets, custom-made dentures, dental devices, and even specialty equipment such as housings and mechanical parts.

What materials are they made of?

Alexandre d’Orsetti: “We use biocompatible materials such as medical-grade polymers and metals.”

For which patients and for what pathology are they intended?

Alexandre d’Orsetti: These devices are intended for patients requiring surgical interventions, tooth correction, orthopedic support or prosthetic limbs, to treat pathologies such as bone fractures, tooth misalignment, loss of limbs and other conditions requiring precise and tailored medical solutions.

What opportunities does this milestone open for Sculpteo in terms of market expansion and partnerships?

Alexandre d’Orsetti: “Achieving ISO 13485 certification significantly expands Sculpteo’s market opportunities, enabling us to penetrate deeper and compete in the global medical device market. We have already been very active in this sector, but this will open the door to cooperation with hospitals, clinics, dental offices and orthopedic centers looking for reliable and certified 3D printed solutions. Additionally, this certification increases our attractiveness to medical device manufacturers looking to outsource high-quality components, thereby supporting collaborations that can drive innovation and efficiency in medical technology.

How does achieving ISO 13485 certification align with Sculpteo’s long-term strategic goals?

Alexandre d’Orsetti: “Obtaining ISO 13485 certification is a key step in Sculpteo’s strategic plan to become a leader in the medical 3D printing industry, which is one of our key segments. This is consistent with our long-term goals, ensuring we meet the stringent regulatory requirements needed to produce components for medical devices, thereby increasing our credibility and trust with healthcare providers and patients. The sector has been growing at a steady pace for many years, and this certification supports our mission to deliver cutting-edge, tailored medical solutions that ensure patient safety and improve healthcare outcomes.

Could you describe the rigorous processes Sculpteo has implemented to meet its certification requirements?

Alexandre d’Orsetti: “To achieve ISO 13485 certification, Sculpteo has implemented rigorous quality management processes, including comprehensive documentation and traceability systems, rigorous testing and validation procedures, and continuous monitoring and improvement protocols. We have created a robust risk management framework to identify and mitigate potential issues throughout the production lifecycle. Our team has undergone extensive training to ensure these processes are followed, and we have conducted internal and external audits to maintain compliance with the highest standards of medical device manufacturing.”

How will Sculpteo maintain compliance and ensure consistent quality during medical device manufacturing?

Alexandre d’Orsetti: “We will maintain compliance and ensure consistent quality by adhering to our established quality management system, which includes continuous monitoring and regular audits. We will keep up to date with regulatory changes and industry best practices, ensuring the appropriate development of our processes. Additionally, we will invest in ongoing employee training and advanced manufacturing technologies to maintain the precision and reliability of our production processes. Customer feedback will be actively solicited and incorporated for continuous improvement.

Could you share your insights on new materials, medical devices, or manufacturing techniques that Sculpteo is exploring?

Alexandre d’Orsetti: “At Sculpteo, we have been producing medical devices for several years, and the application areas we have identified mainly include orthopedic devices, dental and surgical aids. We will produce components for Class I and IIa medical devices primarily using our existing machinery and primarily powder bed technology machines. These machines are the most suitable equipment for series production and fall within the scope of our ISO13485 certification. The use of these technologies in medicine is relatively recent, so we will most likely develop tailored solutions and discover new applications in collaboration with healthcare professionals.”

Are there any specific medical applications or use cases that Sculpteo wants to address with its certified products?

Alexandre d’Orsetti: “Our certified products are intended for several specific medical applications, including orthopedic devices such as O&P (orthoses and prosthetics) for the lower and upper limbs. We focus on custom-made prosthetics to improve the mobility and quality of life of amputees. Our experience in additive manufacturing combined with our BASF forward AM service team allows us to design dedicated workflows such as network generation to leverage end-to-end solutions, from automatic 3D file generation to delivery. There is also a high demand for surgical support devices to help prepare training for a surgical operation or to produce tools during surgery. These applications underscore our commitment to providing solutions tailored to the individual needs of each patient.

How does the company plan to engage with healthcare providers and other stakeholders?

Alexandre d’Orsetti: “Sculpteo plans to collaborate with healthcare providers and other stakeholders through partnerships, joint research and development projects and educational initiatives. Our goal is to work closely with surgeons, dentists and medical researchers to develop and refine our products, ensuring they meet clinical needs. We see a huge opportunity in collaborating with industry experts to provide dedicated and automated workflows, leveraging our software and design generation capabilities. Additionally, we will participate in conferences and industry forums to share knowledge and insights, creating a collaborative environment that drives innovation and improves patient care.”

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