“InnoVoyce is driven by the principles of advancing healthcare through innovative, patient-focused technologies,” said Michael Davin, CEO of InnoVoyce. “Achieving ISO 13485 certification validates our commitment to maintaining the highest quality standards, while the nationwide availability of our VYLO Laser System marks a significant step in making best-in-class surgical solutions accessible to providers and patients across the country.”

ISO 13485 is a globally recognized benchmark for quality management systems specific to medical devices, ensuring safety, reliability, and performance. InnoVoyce successfully completed rigorous audits by TÜV USA, confirming its quality management system complies with all requirements of the ISO 13485:2016 design and manufacturing standards.