The eval question I get asked most often is not "does the QMS do X." It is "what does it actually cost when we are not on the cheapest tier anymore." I have spent enough budget cycles on this to have opinions, and to be fair, the vendors have reasons for opacity. The reasons just do not help me.
A bit of context, because the answer matters more in some shops than others. I sit on the EU side of MDR for a mid-size Class IIa/IIb manufacturer. Around ninety people on the QMS — Technical Files, CAPAs, change controls, supplier records, training, complaints, the usual. Every couple of years someone in finance asks whether we still need the eQMS we bought in 2019. I spend two months building a comparison sheet. We stay where we are, because switching costs more than the savings. The exercise is not really about saving money. It is about being able to tell the notified body — TÜV in our case, you will have your own — that we evaluated our tools with reasonable due diligence. Per ISO 13485:2016 clause 4.1.6, and arguably under MDR Article 10(9) for the manufacturer's QMS obligations, validation of software used in the QMS is something the auditor will walk through at the next surveillance audit.
The price that is on the website is the price that gets you in the door. That is normal. I am not going to pretend it is not. Most enterprise software works this way — seat counts, integration modules, validation packs, premium support, all of it gets layered. The problem is that for a regulated QMS, the tier above the entry tier is not a nice-to-have. It is where the work actually lives.
What the entry tier is, in practice
The entry tier is the demo that wins the demo. It usually gets you:
- A handful of modules (often document control and training, occasionally CAPA)
- A seat count that sounds generous and quietly excludes read-only users, or counts them as half, or counts them as full
- A support tier that responds in 48 hours and does not include a named CSM
- An audit trail that exists but is not necessarily exportable in the format your auditor will ask for
You can absolutely run a pilot on it. You can absolutely impress a procurement team on it. You cannot run a Technical File review process on it, because the connected workflow to risk management, post-market surveillance, and change control is not there. You cannot do electronic signatures in a way a notified body will accept without an add-on. You cannot pull the audit trail report your NB auditor will ask for during the surveillance audit without paying for the export module.
In practice this means the tier you need is the tier you cannot price before you buy.
Why vendors do not publish the second-tier price
To be fair, I understand the logic.
- They want a sales conversation, not a procurement comparison. A negotiated deal is worth more than a published one.
- Real prices depend on seat counts, modules, validation scope, and whether you want the SLA that promises a 4-hour response when your CAPA queue is on fire.
- The mid-market is messy. A 50-person company and a 500-person company are not the same customer, even if they buy the same product.
Granted. None of that is unreasonable. But it puts the burden on the buyer — the person with the CAPA backlog, the next audit in Q3, and a finance director who wants a number, not a sales call.
What I would actually want to see on a pricing page
A published matrix, even with a "starts at" qualifier. Something like:
- Entry tier: published
- Compliance tier: published range, with a clear list of what unlocks
- Validation pack: published price or published calculator
- Audit trail retention beyond the default window: published
- SSO/SAML: published, or clearly marked as Enterprise only
I do not need the exact price for a 200-seat, three-site, SSO-required, validation-pack-included deployment. I do need to know whether the gap between "what I am quoted now" and "what I will pay in year two" is a 20% gap or a 300% gap. That single number changes the procurement conversation, and it changes whether the renewal will survive a budget review.
The MDR angle, briefly
This matters more for us than for a generic SaaS buyer, because the choice is constrained. Per Annex II of MDR, the Technical File has to demonstrate that the manufacturer's QMS supports the device lifecycle. Per Article 10(9), the manufacturer has obligations around validation, monitoring, and updating of the QMS itself. If the tier you actually need is the one that supports validation evidence, electronic signatures compliant with the relevant Annex, and audit trail retention that matches your retention policy — that is not a budget question. That is a regulatory question that happens to have a budget number attached.
When I see a vendor publishing the entry price and quoting the rest — qmsWrapper is one, but they are not unusual in this — I do not blame them. They are normal for the category. I just wish the category were less annoying. The price you cannot find is the price that decides whether you will renew, and whether you can defend the renewal to a finance director who is not a regulatory specialist.
The buyer side, for what it is worth
Two things have saved me in the last cycle:
- Asking the vendor, in writing, what the tier above the entry tier includes and what triggers the move. Not "what does Enterprise include" — what triggers the move from one tier to the next. The answer is usually more illuminating than the brochure.
- Asking for a one-page change-order cost list. What does it cost to add seats, add modules, extend retention, add SSO, add a second site. If they will not put that on paper, the answer is "we will figure it out when you are locked in."
Neither of those is glamorous. Both are cheaper than the alternative, which is discovering in year two that the connected workflow you actually need sits behind a price no one would quote you in year one.
For those of you who have been through an eQMS eval recently — what is the one number you wish had been on the pricing page instead of behind the sales call?
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