MoniDoseQMS at Healthtech Finland's eQMS Meeting — An In-House Quality System Alongside the Industry's Leading Platforms

On 19 May 2026, Healthtech Finland (Terveysteknologia ry) brings its medical device working group together in Helsinki for a joint meeting on electronic quality management systems. MoniDose CEO Alaa Salonen closes the programme by presenting MoniDoseQMS in English.

Systems from the User's Perspective

The meeting has a clear premise: each system is presented from the user's point of view — not as a sales pitch, but as the lived experience of what quality management feels like day to day. For MoniDose, that is a natural starting point. We do not present MoniDoseQMS as a platform we sell, but as the system we use ourselves, every day, to build a Class I medical device under EU MDR 2017/745.

An In-House System, a Real Need

Most startups buy a ready-made quality management system. MoniDose built its own. The reason was simple: we needed a system light enough for a small team, rigorous enough for regulatory scrutiny, and flexible enough to grow with us.

MoniDoseQMS covers document control, CAPA, risk management and deviation handling — all tied to the requirements of ISO 13485, ISO 14971, IEC 62304 and EU MDR. Every workflow answers a real regulatory need, because it was built for one.

Alongside the Industry's Leading Platforms

The programme features established commercial eQMS platforms. MoniDoseQMS is the only purpose-built, in-house system on the agenda — a small Finnish health-tech company's own quality system, discussed at the same table as the field's experienced players.

It is exactly this regulatory maturity that our investors have praised. For an early-stage company, an in-house eQMS is unusual — for us, it is part of how we build.

Event at a Glance

MoniDoseQMS is available at monidoseqms.com. MoniDose is being developed as a Class I medical device (with software) under EU MDR 2017/745; the device is not yet registered, and registration with Fimea is planned.