04/06/2026
We are excited to announce that Inovytec has successfully achieved MDSAP certification.
This achievement reflects our commitment to quality, regulatory excellence, and continuous improvement, while supporting our expansion into international markets and strengthening our ability to serve customers worldwide.
Our quality system aligns with key global regulatory frameworks:
✅ISO 13485:2016
✅Australia: TG (MD) Regulations, 2002, Schedule 3 Part 1 (excluding Part 1.6) - Full
✅Canada: Medical Devices Regulations – Part 1 – SOR 98/182
✅United States: 21 CFR 820, 21 CFR 803, 21 CFR 806, 21 CFR 807 (Subparts A to D)
✅Japan: MHLW MO No 169 (2004), as amended by MHLW MO No 60 (2021), PMD Act
A big thank you to our Quality, Regulatory, Operations, and cross-functional teams whose hard work and commitment made this achievement possible.