Aitech International ApS

QMS Nordic combines an integrated electronic quality management system (eQMS) with regulatory and quality consultancy for medical device and in vitro diagnostic manufacturers. We help companies replace fragmented spreadsheets, documents and manual processes with a connected platform that supports EU MDR, IVDR and ISO 13485 requirements.

Our 360° approach brings together document control, technical documentation, production traceability, post-market surveillance, complaints, corrective and preventive actions (CAPA), training, supplier management and audits. By connecting these activities, QMS Nordic helps teams maintain oversight, reduce repetitive administration and keep records accessible for daily operations and audit preparation.

The platform supports manufacturers working with devices from Class I to Class III, including medical device software. Guided workflows and an AI assistant help users navigate documentation and quality tasks, while ERP integrations connect quality records with production and traceability data.

Alongside the software, our consultancy services provide practical support with quality system development, regulatory documentation and ongoing compliance activities. Companies can combine the platform with expert assistance according to their needs and internal resources.

With European hosting, pricing without per-user fees and hands-on onboarding, QMS Nordic makes comprehensive quality management accessible to growing manufacturers. Our aim is to help medical device companies spend less time managing administration and more time developing and delivering safe, effective products.