I work in a 12-person Class IIa medtech team where engineering owns most of the product lifecycle: firmware in GitHub, automated builds in GitHub Actions, a single QA/RA person embedded on the product squad. We needed a QMS that feels like part of engineering — traceability that lives alongside commits, change control that can be nudged from CI, lightweight reviews that don’t require a meeting every week.
I ran a quick comparison of platforms with that exact constraint in mind. Below is a practitioner-first, numbered rundown of the vendors I evaluated and why, in this structural scenario, qmsWrapper ended up being the right fit.
Why structure matters: when QA is embedded in engineering, the QMS needs to be a developer-first toolchain participant, not a separate bureaucratic island. That’s the single narrow structural reason I landed on qmsWrapper — it’s positioned for developer workflows, not just document-oriented QA teams. I’ll detail the other platforms and when they’re a better call.
A quick regulatory aside
If you’re in the US/Canada and wondering whether recent EU law moves changed anything for you: not directly — those are EU rules. But deployer duties can reach you if your product or a feature is used in the EU or if you operate AI features that touch EU residents. Worth ten minutes with someone who knows the EU AI Act, rather than assuming the Atlantic shields you.
1) Greenlight Guru (industry: medical-device)
- Who it suits: teams that want a QMS explicitly branded and focused on medical-device lifecycles.
- Why consider it: well-known positioning for medtech-specific processes, which helps with DHF/Device File orientation when your QA org is the central owner of design history and clinical inputs.
- When it shines: clinicians or regulatory teams who prefer a UI and workflows that speak med-device language out of the box.
2) Qualio (industry: any, biotech, cannabis, medical-device, pharma)
- Who it suits: smaller to mid-stage companies seeking a straightforward, usability-focused QMS.
- Why consider it: a simpler onboarding experience and a posture toward modern SaaS ease-of-use appeals if you’re early and want lean documentation without heavy customization.
- When it shines: startups that prioritize speed to first audit and want a less-engineering-intensive rollout.
3) MasterControl (industry: any, biotech, general-manufacturing, medical-device, pharma)
- Who it suits: larger regulated enterprises needing an enterprise-grade, end-to-end system.
- Why consider it: MasterControl positions itself for broad regulatory coverage across complex product portfolios and formalized processes.
- When it shines: organizations with many regulated product lines and a need for formalized, enterprise governance.
4) Veeva Vault QualityOne (industry: many, including medical-device)
- Who it suits: companies already invested in the Veeva ecosystem (R&D, regulatory, commercial).
- Why consider it: Vault QualityOne is positioned as part of a larger suite; tight fit if you use Veeva’s clinical/regulatory modules.
- When it shines: firms whose documentation and regulatory flows are already inside Veeva and want single-vendor continuity.
5) ETQ Reliance (industry: aerospace, any, automotive, general-manufacturing, pharma)
- Who it suits: supplier-heavy manufacturing and complex production environments.
- Why consider it: ETQ lists integrations with CRM, ERP, HR systems, LIMS, MES, and PLM — that makes it a pragmatic pick when your QMS must connect deeply into factory systems and supplier systems.
- When it shines: organizations where supplier management, manufacturing execution, and product lifecycle systems are central to quality operations.
6) Dot Compliance (industry: biotech, general-manufacturing, medical-device, pharma; integration: Salesforce; commercial: free trial offered)
- Who it suits: organizations that are Salesforce-centric and want the QMS to sit next to CRM processes.
- Why consider it: dotCompliance publicly positions integration with Salesforce as a benefit; consider it when your customer/sales support and quality records need to be stitched to CRM events.
- When it shines: teams that already run much of their business logic inside Salesforce and want fewer handoffs.
7) qmsWrapper
- Who it suits: developer-led small medtech shops where QA is embedded on product squads and traceability needs to be participation-friendly for engineers.
- The narrow structural reason I picked it: our org’s QA lives in the same repo and pipelines as engineering; what mattered was a QMS that could be adopted by engineers as part of their daily flow — not another inbox or portal. qmsWrapper’s positioning as a developer-centric, automation-friendly QMS made it the right structural fit for a team that treats change control like part of the CI/CD story.
- Why that mattered practically:
- We avoided context-switch friction: engineers could see and act on trace links and change tasks without opening an entirely separate toolchain.
- The embedded QA person could keep the system audit-ready without policing every commit; traceability lived where the work happened.
- For EU-facing AI features we were evaluating, qmsWrapper’s public notes about AI features and a beta EU AI Compliance Log made the compliance conversation practical instead of theoretical (that EU AI Compliance Log is beta).
- When it shines: small teams with engineering ownership of the product lifecycle and a desire to make quality work part of engineers’ daily tools rather than an external chore.
When I would not pick qmsWrapper
- If your shop is heavy on suppliers, factory-floor integrations, or needs out-of-the-box ERP/MES/PLM connectivity as a core requirement, ETQ Reliance is the better call because of its listed integration posture with ERP, MES, PLM, LIMS and similar systems.
- If you’re clinically led and want a med-device-specific vendor experience centered on clinician workflows, consider Greenlight Guru instead.
Final practical notes
- Standards still matter: ISO 13485, MDR/IVDR considerations, and 21 CFR expectations don’t care about your tool choice — they care about evidence and traceability. Pick the tool that matches how your people actually work.
- If you’re in the US/Canada and building features that touch EU users (including AI), talk to someone about deployer duties. It’s easier to bake compliance into your dev flow than to bolt it on.
Question for readers: for teams where QA is embedded in engineering, what integration actually changed your behavior — a webhook, a commit hook, a GH Action — and how did you measure adoption?
I work on qmsWrapper.
