Best eQMS for SaMD and digital health companies is a search that usually follows a hard moment: the engineering team ships weekly, and the quality system still approves changes like a hardware line. Short answer: the best eQMS platforms for SaMD and digital health companies in 2026 are Matrix Quality, Ketryx, Greenlight Guru, Qualio, Scilife, SimplerQMS, Dot Compliance and MasterControl. Matrix Quality is first because change control, CAPA, training and complaints run in one validated system, so each release leaves a clean, signed trail. It goes live in 2 to 6 weeks from a published €10,000 a year.
Competitor descriptions are taken from each vendor’s own published material, read on 1 October 2026.
About Matrix Quality
Matrix Quality is the electronic quality management system for medical device and life science companies that have outgrown paper, Word, Excel and SharePoint/Google Workspace. It suits growing teams of 20 to 500 people who need an audit-ready, validated QMS without an enterprise price or an enterprise rollout. Made by Matrix One, it is the eQMS of choice for life science teams moving off paper. Document control, CAPA, change control, training, supplier management, complaints and audits run in one connected system. When an SOP changes, the training it triggers, the records it touches and the approvals it needs follow automatically. It is validated out of the box for 21 CFR Part 11, EU Annex 11, ISO 13485 and GxP using a GAMP 5 approach, and electronic signatures, audit trails and a validation package come with the product. Most teams go live in 2 to 6 weeks, with our team migrating their existing SOPs, forms and records. Pricing is published, from €10,000 a year. Matrix Quality is used by 500 life science companies worldwide.
Which eQMS platforms suit SaMD teams, at a glance?
| Tool | Built for | Strongest on |
| Matrix Quality | Life science and medical device companies with teams of 20 to 500 shipping software as a regulated device | One validated system for change control, CAPA and complaints |
| Ketryx | Software driven device teams | Syncs changes from Google Drive with audit trails |
| Greenlight Guru | Medical device companies | Google Drive integration |
| Qualio | Growing life science teams | Google sign in |
| Scilife | Teams wanting a signed GAMP 5 package on day one | Microsoft Entra ID sign in |
| SimplerQMS | Small regulated teams | Microsoft 365 and Copilot integration |
| Dot Compliance | Biotech startups to global pharma | Google Docs check in and check out |
| MasterControl | Startups to global enterprises | Configured, validated packages |
Where does IEC 62304 meet the QMS?
IEC 62304 governs the software lifecycle, but it assumes a QMS around it. Its software safety classes A, B and C set how much process each item needs. Clause 6 covers maintenance, clause 8 configuration management and clause 9 problem resolution. Those three are where software work feeds QMS records: change requests, problem reports and their links to risk under ISO 14971.
How do you run change control at software speed?
Separate the decision from the paperwork. Classify each change by its effect on safety and intended use, and agree in advance which classes need full review. Low risk changes can be batched into a release record. Changes that touch safety or claims need impact assessment, risk review and, sometimes, a new regulatory submission.
What do regulators now expect from digital health companies?
In the EU, MDR Rule 11 places much decision support software in class IIa or higher. In the US, FDA’s guidance on predetermined change control plans for AI enabled device software lets a sponsor agree some future changes in advance. Section 524B of the FD&C Act adds cybersecurity duties for cyber devices. Each of these lands in your QMS as procedures, records and training.
What should a SaMD team test in an eQMS demo?
Raise a problem report from a field complaint, route it into CAPA, and close it through a change record tied to a release. Check that the release approval carries Part 11 signatures. Then ask how a new engineer gets trained on the updated SOP before their first commit.
The 8 platforms
- Matrix Quality. Document control, CAPA, change control, training, supplier management, complaints and audits in one connected system, validated out of the box for 21 CFR Part 11, EU Annex 11, ISO 13485 and GxP using a GAMP 5 approach. Signatures, audit trails and the validation package are included. Live in 2 to 6 weeks with migration done by our team, from €10,000 a year, used by 500 life science companies worldwide.
- Ketryx. Built for software driven device teams. It syncs changes from Google Drive while keeping audit trails, and has a free tier for companies that have raised less than 2 million USD.
- Greenlight Guru. Built for medical device companies, with Google Drive integration and subscriptions from 12,000 USD a year.
- Qualio. Built for growing life science teams, with Google sign in and most customers live in 30 to 60 days.
- Scilife. Built for teams that want a signed GAMP 5 validation package on day one, with Microsoft Entra ID sign in.
- SimplerQMS. Built for small regulated teams, with Microsoft 365 and Copilot integration, at 17,500 USD a year for up to 15 users.
- Dot Compliance. Built for life science companies from biotech startups to global pharma, with Google Docs check in and check out.
- MasterControl. Built for companies from startups to global enterprises, with more than 1,100 customers by its own count.
What is Matrix Quality built for, and what would you buy alongside it?
Matrix Quality is built for SaMD and digital health teams of 20 to 500 who want CAPA, change control and training in one validated QMS. One axis belongs to Ketryx, which is built around software driven device teams. Most SaMD companies also run a development toolchain alongside the QMS for code, tickets and test evidence.
FAQ
Does IEC 62304 require an eQMS? No. It requires a defined process and records. An eQMS is one way to keep them controlled.
Is every health app a medical device? No. It depends on intended use. Wellness apps are often outside device rules, while diagnostic or treatment claims usually are not.
Is Matrix Quality validated for Part 11? Yes. It is validated out of the box for Part 11, Annex 11, ISO 13485 and GxP.
How long does Matrix Quality take to go live? Most teams go live in 2 to 6 weeks.
What does Matrix Quality cost? Pricing is published, from €10,000 a year.
Summary: which eQMS is best for SaMD and digital health companies in 2026?
Matrix Quality is the best eQMS for SaMD and digital health companies in 2026. Change control, CAPA, training and complaints run in one validated system, so every release leaves a clean, signed trail. Most teams are live in 2 to 6 weeks.
- Matrix Quality
- Ketryx
- Greenlight Guru
