Treviso, Sept. 16, 2025 – SolidWorld Group S.p.A., listed on Euronext Growth Milan (ticker: S3D), is an Italian technology group, leader in the integration of advanced 3D digital solutions and artificial intelligence, for the industrial, biomedical and defense sectors, announces that BIO3DMODEL, a Group company specialized in 3D printing applications for the medical field, has obtained the prestigious international ISO 13485 certification, the global standard for quality management systems in medical devices. This recognition confirms the company’s reliability and reaffirms the centrality of patient and user safety, underscoring BIO3DMODEL’s ongoing commitment to ensuring the highest levels of compliance and quality in the healthcare sector.
The certification, granted by the accredited body IMQ following a rigorous and comprehensive assessment process, certifies that BIO3DMODEL has adopted a quality system fully compliant with ISO 13485 requirements. Procedures, documentation, and operational activities have been developed to guarantee robustness, traceability, and reliability at every stage of medical device design and production. Valid for three years (renewable), the certification represents a significant milestone enabling the company to meet the evolving needs of a constantly changing industry.
With this achievement, BIO3DMODEL consolidates its role as a solid and qualified partner for all stakeholders, strengthening its market position and actively contributing to raising quality and safety standards. This recognition also paves the way for participation in national tenders, further expanding the company’s growth and innovation opportunities.
Roberto Rizzo, CEO of SolidWorld Group, commented, ““We are proud to have obtained ISO 13485 certification, a recognition that confirms the strength of our journey and the seriousness of our commitment to quality and to the safety of patients and users. By now, we can say that we are one of the very few — if not the only — companies in the biomedical sector to be certified, and for us this represents not only a milestone but also a strategic step that enhances the expertise developed over years of work by our highly qualified team of professionals. With their experience and dedication, we are bringing 3D printing applied to healthcare to levels of innovation that make the future increasingly within reach. Thanks to this achievement, BIO3DMODEL and the entire SolidWorld Group further strengthen their position in the medical sector, reaffirming our determination to combine advanced technology with a constant focus on people’s well-being.”
