Flash Pathology is proud to announce that it has officially achieved ISO 13485 certification, marking an important milestone as the year comes to a close.

This certification demonstrates Flash Pathology’s commitment to meeting the highest international standards for the development of medical devices and reflects its ongoing dedication to quality, safety, and reliability for partners and customers worldwide.

This achievement would not have been possible without the hard work and dedication of the entire team. A special acknowledgment goes to Mónica Gómez-Angulo Martínez, Quality Manager, for her leadership and contribution throughout the certification process.

This milestone further strengthens Flash Pathology’s mission to advance tissue analysis through cutting-edge, label-free imaging technologies. The company’s Flash Scanner FS4-R enables rapid, subcellular-resolution 2D and 3D imaging of fresh, unprocessed tissue, without staining, labelling, or sectioning. By preserving tissue integrity for downstream molecular and genetic analysis, Flash Pathology supports high-precision diagnostics, intraoperative decision-making, and translational research, underpinned by a quality management system certified to ISO 13485 standards.