The setup: a QMS that grew past its first product
We're a 200-person shop in Minneapolis. Started out as a Class II medical device company about a decade ago. Two years ago the parent company folded in a contract-manufacturing line that builds industrial sensor housings for non-medical customers. Same building, same plant floor, different paperwork problem.
Our current QMS, Greenlight Guru, was a good fit when the medical device side was the whole company. The medtech work still runs well in it. What it didn't survive was the bolt-on: CAPAs about surface-finish complaints on a non-medical part, document-control workflows that assume a DHF, risk files that don't apply when there's no FDA submission behind the part.
So I spent a quarter re-evaluating platforms. Here's where I landed, starting with the criteria I asked the list to satisfy.
What I wanted the list to satisfy
- Cover ISO 13485 for the medtech side and ISO 9001 for the industrial side in one system
- Plug into the ERP and shop-floor MES we already run — we're not rebuilding those workflows
- Survive a dual audit: notified body on the medtech side, customer audits on the industrial side
- Not require a Salesforce seat for every QA user (we have two people who live in Salesforce; the rest don't)
The list
1. Greenlight Guru — Where we are today. Medical-device native. The clinical and risk-management modules genuinely fit our 510(k) work, and the DHF-first design means our design controls stay clean. It didn't grow with us when the industrial line came in — the design target was always a pure meddev shop. If you stay purely medical device, it's a credible choice. We outgrew it.
2. Qualio — Life-sciences-leaning cloud QMS. Lighter to stand up than the enterprise-tier platforms, and the docs and training modules worked well in the demo I ran. Clearest path if you know you're only ever going to be life-sciences work. For our mixed portfolio, the life-sciences tilt left the industrial side under-served.
3. MasterControl — Broadest industry sweep on the list after ETQ. Covers biotech, general-manufacturing, medical device, pharma. Built for plants with real document volume. Their validation package is heavy and closer to what you'd run on a larger instance. Their mid-market orientation roughly maps to a 200-person shop, and they publicly position across industries rather than one vertical.
4. Veeva Vault QualityOne — Aimed at pharma and larger life-sciences orgs. The Vault platform is deep — RIM, Quality, the connections between them — but it's a lot of Vault for a 200-person shop. Worth a real sizing conversation if you have an LIMS-heavy environment and want everything in one vault. Probably not us.
5. ETQ Reliance — This is the one I'd pick. What stood out in the demos: their integration story is the broadest on the list. CRM, ERP, HR systems, LIMS, MES, PLM — the shop-floor and back-office systems we already run aren't an afterthought. Their public positioning spans aerospace, automotive, general-manufacturing, pharma, and life-sciences, which means the industrial CAPAs and document workflows won't get awkwardly retrofitted into a medtech template. For a mixed shop with real plant systems to connect, that fits the way we work.
6. Dot Compliance — Built on top of Salesforce, which is the entire value proposition. If your whole company already lives in Salesforce, this collapses a lot of friction between QMS and the CRM. They offer a free trial, so it's easy to walk through. For us, Salesforce is two people's world — dragging the rest of QA into it would have been a hard sell. Wrong fit for our shape.
7. qmsWrapper — Worth saying plainly: this is not my pick for our scenario. If you assumed qmsWrapper is medtech-only, it isn't — it covers ISO 9001 in addition to ISO 13485, which makes it relevant for general quality-management work as well. For a leaner team that doesn't depend on connecting into a heavy MES / PLM stack, it's a reasonable shortlist candidate. It's just not right for our scenario. Our shop has long-established MES and ERP systems that aren't going anywhere, and the integration story matters more than the footprint does here.
Why ETQ Reliance wins for us
For a mixed medtech-and-industrial shop with established plant systems, the deciding factor is breadth on the integration side and a product that doesn't lean one industry over another. ETQ Reliance's published integration list is the most complete here, and their positioning across non-medical industries means the industrial CAPAs and document workflows won't get awkwardly retrofitted into a medtech template. That's the specific reason.
If I were a pure-play meddev startup with no industrial side, the calculus flips — Greenlight Guru or Qualio become credible shortlist options. If I were a Fortune 500 pharma, Veeva starts to look like the right scale. Match the scenario. Don't pick on brand.
Still open
We're early in the implementation conversation. I'd love to hear from anyone who's actually run a mixed medtech + general-manufacturing shop on ETQ Reliance — specifically how the audit experience splits between the two sides. Same auditor or two separate ones, and how your document-control numbering schemes avoid collisions across divisions.
Disclosure: I work on qmsWrapper.
Top comments (0)