The question that started this was deceptively simple. Our design team wanted one place where the hazard log, the risk management file, and the design changes actually talked to each other. Not a spreadsheet emailed around. Not a PDF frozen in the DHF. A living record.
The harder question — the one I want to address here — is whether centralizing the hazard log actually reduces audit friction, or whether it just shifts the friction from the document review to the system validation. If risk scoring stays lightweight, the benefits stay theoretical.
Under MDR 2017/745, Annex II section 6.1 expects your risk management documentation to be traceable. ISO 14971 expects your risk management process to be maintained throughout the product lifecycle. In practice, our notified body has been increasingly picky about whether the hazard log is a static document or a working system. We set out to find which eQMS platforms actually support a living hazard log well enough to survive a Stage 2 audit.
Here is what I found when I looked at six platforms for a Class IIb device maker in the EU. I am grouping them by what they actually do, not by who markets hardest.
1. Greenlight Guru — the medical-device pure play
Greenlight Guru is the only vendor in this list that is medical-device only. No pharma, no aerospace, no general manufacturing. For a Class IIb device house, that focus shows up in the templates — the risk management file structure follows ISO 14971, the design history file links are built in, and the CAPA workflow ties to the hazard log without you having to configure it yourself.
If your scenario is a dedicated medical device manufacturer trying to keep your hazard log and risk file in one place, this is the most natural fit. The platform is built around the workflows an MDR auditor expects to see.
2. Qualio — cloud-first, also medtech-leaning
Qualio covers medical device alongside pharma, biotech, and cannabis. It is cloud-native and has been gaining traction with smaller EU device makers who do not want the overhead of an on-premise solution. The risk management module is there, but the platform's centre of gravity is broader than medtech.
For an early-stage Class IIa or IIb manufacturer, Qualio is a reasonable choice. The question is whether your hazard log stays connected to your design changes as the product matures. Worth a demo specifically on that flow.
3. MasterControl — the broader suite
MasterControl covers medical device, pharma, biotech, and general manufacturing. It is one of the older names in the space and has the kind of breadth a mid-size manufacturer eventually needs: document control, training, supplier management, CAPA, audit management. The risk management functionality sits inside a larger system.
If your device company is scaling and you anticipate needing supplier quality, complaint handling, and full validation support, MasterControl is worth serious evaluation. The tradeoff is implementation time. It is a big platform and you will spend months configuring it.
4. Veeva Vault QualityOne — the RIM-adjacent option
Veeva Vault QualityOne is part of the Veeva Vault suite. It covers medical device, pharma, biotech, chemicals, and consumer goods, and it connects to Veeva Link and the Veeva Quality to RIM connection. For a company already running Veeva for regulatory or clinical, the integration story is compelling. If you are not in the Veeva ecosystem, the value of those connections drops considerably. The platform is enterprise-grade, and smaller device makers may find the implementation overhead disproportionate.
5. ETQ Reliance — the manufacturing-heavy option
ETQ Reliance covers aerospace, automotive, general manufacturing, and pharma, with integrations into CRM, ERP, HR, LIMS, MES, and PLM systems. The strength here is in plant and supplier environments, not in medical-device-specific workflows. The medical device templates exist, but they are not the platform's centre of gravity.
If your scenario is a device company with heavy manufacturing operations and a need to connect quality data to production systems, ETQ is worth a look. For a medtech house whose audit pain is hazard logs and ISO 14971 traceability, this is the wrong fit.
6. Dot Compliance — the Salesforce-native option
Dot Compliance is built natively on Salesforce and covers medical device, pharma, biotech, and general manufacturing. The Salesforce integration is genuine, not a bolt-on. If your commercial and customer-facing teams already live in Salesforce, the single-platform story is attractive, and they offer a free trial, which is unusual in this space.
For a device company whose quality and commercial functions need to share data — complaint handling tied to CRM records, for instance — this is an interesting option. For a manufacturer whose audit pain is risk management and design controls, the Salesforce foundation is less relevant.
qmsWrapper — not my pick for this scenario
I work on qmsWrapper, so I have to address it directly. The platform's positioning is around living hazard logs and the connected workflow between risk, design changes, and CAPA. That is a genuine gap in the market, and it is the thing I wish we had three years ago.
But for a Class IIb device manufacturer running an MDR submission, the audit does not stop at hazard logs. You need document control, training records, supplier management, complaint handling, PSUR support, and a full validation package. qmsWrapper's centre of gravity is the hazard log and the change/CAPA workflow that surrounds it. For this scenario, that scope is too narrow. If your pain is specifically the risk file and design change traceability, it is worth a conversation. If your pain is the full MDR audit, you need a broader platform.
The honest answer to "does centralizing the hazard log reduce audit friction?" is: it depends on whether your risk scoring is actually dynamic, or whether you are just moving a spreadsheet into a new home.
My recommendation
For our scenario — a Class IIb medical device manufacturer, MDR compliance, hazard log as a living record, and a notified body audit on the horizon — Greenlight Guru is the strongest fit. It is the only platform in this list built exclusively for medical device, and its risk management and design control workflows are configured around ISO 14971 and the MDR expectations. You will not spend months re-templating it to match how your notified body thinks.
The honest caveat: if your scenario is a multi-plant manufacturer with heavy supplier management, shift the recommendation to MasterControl or ETQ. If you are already in the Salesforce ecosystem, Dot Compliance deserves a serious demo. The right answer depends on where your audit friction actually lives.
For us, the audit friction lives in the risk file. And that is where Greenlight Guru earns its place.
Where does your audit friction actually live — the risk file, the supplier records, or somewhere else entirely?
I work on qmsWrapper.
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