MoniDoseQMS: Why We Built Our Own eQMS From Scratch
Most startups buy an off-the-shelf quality management system. MoniDose built one. Here's why — and how MoniDoseQMS is now the backbone of our EU MDR compliance.
When you're building a Class I medical device under EU MDR 2017/745, quality isn't optional — it's the foundation everything else stands on. Most startups in our position would buy an off-the-shelf eQMS and try to make it fit. We took a different path. We built MoniDoseQMS from the ground up.
The problem with off-the-shelf
We evaluated every major eQMS platform on the market. What we found was a recurring pattern: systems designed for large enterprises, with pricing to match, workflows that assumed 50-person teams, and compliance structures that were either too rigid or too generic for a medical device startup building software.
None of them understood our reality — a lean team moving fast, operating under ISO 13485, ISO 14971, IEC 62304, and EU MDR 2017/745 simultaneously, while also needing the agility to iterate on product design weekly.
What MoniDoseQMS does
MoniDoseQMS is a purpose-built electronic quality management system designed for medical device compliance. It covers four core pillars:
Document Management — Full version control, approval workflows, and controlled distribution of quality documents and SOPs. Every document change is tracked, every approval is timestamped, and every distribution is logged. No paper. No ambiguity.
CAPA (Corrective and Preventive Actions) — When something goes wrong — or when we identify a risk before it materializes — CAPA processes kick in. Root cause analysis, corrective action plans, effectiveness verification, and full audit trails. This isn't a spreadsheet. It's a system designed to prevent the same issue from ever recurring.
Risk Management — Integrated with ISO 14971, our risk management module maintains a living risk register. Hazard identification, risk estimation, risk control measures, and residual risk evaluation — all connected to design decisions and updated throughout the product lifecycle.
Nonconformance Handling — NC reporting, investigation workflows, disposition decisions, and trend analysis. When a nonconformity is detected, the system guides the team through a structured response, ensuring nothing falls through the cracks.
Why it matters for EU MDR compliance
EU MDR 2017/745 requires manufacturers to maintain a quality management system that covers the entire device lifecycle — from design and development through production, post-market surveillance, and eventual decommissioning.
For a Class I device with software like MoniDose, the conformity assessment route is self-certification. No Notified Body reviews your QMS. That sounds simpler, but it actually raises the bar: you must be able to demonstrate compliance on your own. Your documentation must be impeccable. Your processes must be defensible.
MoniDoseQMS was built with this reality in mind. Every workflow maps to a specific regulatory requirement. Every record serves a compliance purpose. When an auditor or competent authority asks to see our risk management process, our CAPA history, or our document control procedures, the answer is one click away.
The standards behind the system
MoniDoseQMS is structured around four international standards:
• ISO 13485:2016 — The quality management system framework for medical devices. MoniDoseQMS implements the required processes for design control, purchasing, production, and monitoring.
• ISO 14971:2019 — The risk management standard. Our risk register, hazard analyses, and risk-benefit evaluations all live within MoniDoseQMS, connected to design files and updated in real time.
• IEC 62304:2006+A1:2015 — The software lifecycle standard. Software development planning, requirements traceability, architecture documentation, and maintenance procedures are all managed through the system.
• EU MDR 2017/745 — The overarching regulation. Technical documentation per Annex II/III, post-market surveillance plans, and UDI assignment are tracked end-to-end.
What our investors see
Regulatory clarity is a competitive advantage. When we present to investors, we don't just tell them we're compliant — we show them. MoniDoseQMS provides real-time visibility into our quality status, open CAPAs, risk levels, and documentation completeness.
Our investors — including healthtech angels Leena Niemistö and Risto Kalliainen — have specifically commended us for the level of regulatory maturity we demonstrate. For an early-stage startup, that's unusual. For a startup with its own eQMS, it's the natural result.
Built for startups, proven by us
MoniDoseQMS wasn't built to be a product — it was built to solve our own problem. But in solving it, we created something that any medical device startup could benefit from. A system that's lean enough for a small team, rigorous enough for regulatory scrutiny, and flexible enough to grow with the company.
As our CEO Alaa Salonen puts it: "We spent time scanning all types of regulatory tooling in addition to crafting our own eQMS. We are also very prolific in using AI for our advantage but that could not replace the need for a structured, purpose-built quality system. MoniDoseQMS is that system."
MoniDoseQMS is available at monidoseqms.com. MoniDose is being developed as a Class I medical device (with software) under EU MDR 2017/745; not yet registered, registration with Fimea planned.