Quality Management, Accessible to All

MoniDoseQMS is built around a familiar frustration in medical device quality management: multiple disconnected tools, compliance documentation that is hard to keep consistent, and countless hours spent on administrative tasks.

We asked ourselves: why should medical device companies need multiple separate software tools to manage their QMS? Why does a startup need to spend tens of thousands on implementation fees before a single document is even created? Why are most QMS platforms designed for large enterprises and priced to match?

Those questions led to MoniDoseQMS — a comprehensive platform with 130+ integrated modules designed from the ground up for regulated industries. We build every workflow, record, and audit trail entry around the requirements auditors check. MoniDoseQMS is built to support companies working to EU MDR, FDA QMSR, ISO 13485, and the EU AI Act.

Then we realised the fragmentation runs deeper than one company’s tools. A manufacturer, the regulatory experts it hires, and the notified body that certifies it all work on the same product — yet each lives in a different system, emailing documents back and forth. So we set out to bring all three under one roof: experts work inside their client’s real QMS with consent, and a dedicated notified-body workspace (pilot programme open) lets assessment and certification happen in the same connected system. One source of truth, for everyone who touches the record.