MDR- IVDR- and FDA-Ready QMS
Quality Management Systems (QMS) that Scale
Modular, scalable QMS solutions aligned with MDR, IVDR, FDA and ISO 13485 — built for MDSW, SaMD, and AI-based products with full audit readiness.
We design and operationalize regulatory-grade Quality Management Systems (QMS) aligned with MDR 2017/745, IVDR 2017/746, FDA 21 CFR Part 820, and ISO 13485:2016. Our solutions are optimized for Medical Device Software (MDSW) and AI-enabled applications, adaptable to specific conditions. A modular QMS architecture translates complex regulatory expectations into actionable, auditable functions — from strategic governance to post-market control. Outcome: faster conformity assessments, fewer audit findings, and sustained readiness for both Notified Body and FDA review. In a situation where you already have a report from Notified Body, we can give a quote on producing a response with the above outcome.