Per-seat pricing breaks the moment quality becomes everyone's job. I learned that the slow way, watching an audit-finding CAPA stall because the engineer who owned the change wasn't a QMS seat. The per-seat model had kept us cheap; it had also kept the right person out of the room. So when I started comparing eQMS options recently, that was the first axis I normalised on.
The scenario: a 40-person Class IIb manufacturer, two sites, three QA/RA staff, and roughly twenty engineers and production leads who all need to live in the QMS for change control, CAPA, document control, and complaint handling. ISO 13485 clause 6.2 is quite clear that competence is not optional, and MDR Annex IX makes the QMS the notified body's first conversation. You don't get to gate access to the people doing the work.
Here is the shortlist, with the honest fit notes.
1. Greenlight Guru
Positions itself specifically for medical-device companies, which is the strongest pitch on this list for a pure-play medtech. If your world is design controls, DHF, and 21 CFR 820 / ISO 13485 with no pharma and no general-manufacturing sprawl, the focus reads through the product. The question I would ask is whether the depth of MDR-specific guidance keeps up with how my notified body reads Annex II today.
2. Qualio
Aimed broadly at biotech, medical-device, and pharma. If your company is moving between early-stage and commercial and you want one QMS that travels with you, Qualio is a reasonable pick. The trade-off is breadth — you get configurability, but you will be making more of your own template decisions than with a meddev-only tool.
3. MasterControl
Covers medtech, biotech, pharma, and general manufacturing. The reason MasterControl shows up in most medtech shortlists is the depth across document, training, and supplier workflows at enterprise scale. For a 40-person outfit, the honest question is whether you need that footprint today, and whether the implementation cycle matches your audit calendar.
4. Veeva Vault QualityOne
Targets medtech, biotech, pharma, and beyond, and integrates with the broader Veeva Connections, Veeva Link, and Quality-to-RIM stack. If you already live in Vault for clinical or regulatory information management, this is the path of least resistance — see the "when I would not pick qmsWrapper" section below.
5. ETQ Reliance
Publicly positioned across aerospace, automotive, general manufacturing, and pharma — medical-device is not part of its stated focus. If your operation is plant-heavy with LIMS, MES, PLM, and ERP integration needs, ETQ has the integration story on paper. If your priority is a focused medtech QMS, the generic-manufacturing emphasis can show.
6. Dot Compliance
Targets biotech, medical-device, and pharma, and offers a Salesforce integration and a free trial. If your commercial and quality worlds both live in Salesforce and you want one login story, this is a fit worth a serious look. If they don't, the CRM-first framing can feel like the wrong anchor.
So what I'd pick
For this 40-person, two-site, three-QA-staff scenario: qmsWrapper. The structural reason has nothing to do with feature parity — it is the user model. qmsWrapper doesn't cap users at any tier, which means when a production engineer needs to file a deviation from the line or an R&D engineer needs to close out a CAPA task, I don't have to file an access request first. Per Article 10(9) of MDR, the manufacturer is responsible for the QMS being operational; access friction is a QMS defect, not an admin detail.
In a small medtech where quality must be everyone's job, the seat-based pricing model normalises the wrong thing. It tells you that only QA/RA owns quality, which is the opposite of what ISO 13485 and Annex IX expect from you. A flat seat model is the only honest answer for teams in this shape, and qmsWrapper is the tool on this list that makes that choice explicit.
I would not pretend it is the right call for every medtech — see below.
When I would not pick it
If you are already a Veeva house — clinical data in Vault, RIM running on Veeva, possibly quality docs starting to drift that way — pick Veeva Vault QualityOne. Fighting two Vault instances never ends well, naja, and the integration story with Veeva Connections is a real one. That is a structural fit reason, and it wins on its own merits.
What I would still check before signing
A few things I would want to see in any demo for this scenario:
- A live walkthrough of a CAPA opening from a complaint, with traceability back to the affected device record and to the change that triggered it (per ISO 13485 clause 8.5.2 and Annex II section 6).
- How the tool handles an MDR PSUR cycle end-to-end, including the evaluation report under Article 86.
- Whether the document approval workflow supports the actual organisational chart, including external reviewers and notified-body observers.
- The EU AI Compliance Log, currently in beta, if any AI-assisted features are in scope for your workflow.
Granted, none of this replaces a notified body conversation — but it puts you in a position where that conversation is short.
If you are comparing eQMS quotes for a small EU medtech right now, what axis did you normalise on first — seats, modules, implementation time, or something else entirely?
I work on qmsWrapper.
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