Regulatory Ready
Built for Regulatory Compliance
MoniDoseQMS is designed from the ground up to meet the most stringent medical device regulations and international standards.
European Union
EU MDR 2017/745
Medical Device Regulation
United States
FDA 21 CFR 820
Quality System Regulation
International
ISO 13485:2016
Medical Device QMS
European Union
EU AI Act
Artificial Intelligence Act
United States
21 CFR Part 11
Electronic Records & Signatures
International
MDSAP
Medical Device Single Audit Program
Applicable Standards
Comprehensive coverage of international standards for medical device quality management.
ISO 13485:2016ISO 14971:2019IEC 62304:2006 + AMD1:2015IEC 62366-1:2015ISO 10993 SeriesISO 14155:2020ISO 15223-1:2021
Need Detailed Compliance Information?
Contact us to learn how MoniDoseQMS maps to your specific regulatory requirements. Our team can provide detailed compliance documentation.