Este, Italy | October 13, 2025 – Biocompatibility Innovation (BCI), a pioneer in advanced biostealth technology for medical devices, today announced that it has achieved ISO 13485 certification, the internationally recognized standard for quality management systems in the medical device industry.
BCI has also successfully renewed its ISO 9001 and ISO 55001 certifications, reaffirming its commitment to operational excellence, robust quality systems, and reliable management of assets and processes.
“Achieving these certifications demonstrates the strength of BCI’s systems and our commitment to driving innovation. They provide a strong foundation as we develop new technologies, ensuring every innovation meets the highest standards,” said Filippo Naso, Chief Technology and Innovation Officer.
ISO 13485, ISO 9001, and ISO 55001 certifications collectively highlight BCI’s commitment to continuous improvement and risk management in the development of technologies that enhance the safety, effectiveness, reliability, and biocompatibility of medical devices. Together, these achievements further strengthen BCI’s quality system which aims to reduce adverse events and improve patient outcomes.
About Biocompatibility Innovation (BCI)
Biocompatibility Innovation is a pioneer in biostealth technology for medical devices and life support equipment. Its technology is engineered to enhance biocompatibility, extend device lifespan, and improve durability, helping reduce healthcare costs while supporting better patient outcomes and improved quality of life. Rapidly scalable and regulatory-friendly, BCI’s platform leverages pharmaceutical-grade, plant-based ingredients to protect prosthetic materials used in medical devices. Founded by scientists and biotech industry executives, BCI partners with medical device manufacturers to bring its disruptive technology to market.