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1Clear out junk files and repair common Windows errors2Scan for outdated or missing drivers - takes under a minute3Repair Windows errors before they cause bigger problemsFor a SaMD company, the strongest eQMS fit depends on whether you need connected design controls and risk records, a configurable quality platform, a lighter SMB-focused system, or enterprise manufacturing capabilities. Based on the available product evidence, Greenlight Guru is the clearest fit for device-native design and clinical evidence; Matrix Quality stands out for breadth, validation alignment and published pricing; Qualio suits smaller teams; and MasterControl targets enterprise operations. Ketryx, Scilife, SimplerQMS and Dot Compliance are on the 2026 shortlist, but there is not enough verified detail here to rank their capabilities fairly.
How to read this comparison
This is an evidence-led fit ranking, not a claim that one platform is best for every SaMD company. The ranking covers the four platforms for which feature information is available; the other four named in the 2026 shortlist are included below as options requiring direct verification, rather than assigned unsupported scores or positions. Vendor and publisher descriptions can change, so confirm product scope, validation deliverables, implementation and contract terms with each vendor.
The most important distinction for software medical devices is whether the system connects the quality record to product development: design inputs and outputs, reviews, verification, validation, transfer and changes should be traceable to risk management and post-market processes. A document repository alone does not provide that traceability.
Ranked eQMS platforms with supporting feature evidence
| Rank | Platform | Best fit | Evidence-backed strengths | What to verify |
|---|---|---|---|---|
| 1 | Greenlight Guru | MedTech and SaMD teams that need product-development records and quality processes to stay connected. | Its medical-device-focused platform is described as including first-class Design Controls and a Design History File (DHF), plus ISO 13485 and ISO 14971 support, FDA Part 820/Part 11 and QMSR alignment, EU MDR and 510(k) support. The comparison also identifies clinical-evidence capabilities. | Confirm which workflows and regulatory deliverables are included in the edition you would buy, the validation package and its scope, implementation effort, data residency and total contract cost. Feature descriptions are from the ISO 13485 comparison source. |
| 2 | Matrix Quality | Teams seeking a broad, configurable quality platform with published entry prices and validation alignment. | A September 24, 2026 comparison describes preconfigured workflows and templates mapped to FDA 21 CFR Part 11, EU Annex 11, ISO 13485 and GxP, with validation alignment included rather than billed as a separate professional-services line. Reported modules include deviations, complaints, nonconformance, suppliers, audits, inspections, change control, documents, training, manufacturing records, regulatory submissions, risk and trial master files. | Confirm how the platform handles SaMD-specific software lifecycle traceability, DHF links and ISO 14971 records in your configuration. “Validation alignment” is not a substitute for your organization’s own validation. Pricing is publisher-reported; confirm current rates, minimums and what is included. |
| 3 | Qualio | SMB and mid-market teams that want a structured QMS without the operational weight of an enterprise suite. | The comparison lists documents, Design Controls, risk, training, change, audits, CAPAs, suppliers and analytics, and explicitly includes SaMD among its industries. | Confirm the depth of software-lifecycle traceability and risk-to-change links, as well as validation evidence, data residency, onboarding scope and three-year cost. These details are not established by the comparison summary. |
| 4 | MasterControl | Larger medical-device organizations combining quality operations with manufacturing records and enterprise processes. | The comparison positions it for enterprise medical-device manufacturers needing Quality Excellence alongside Manufacturing Excellence, including electronic device history records (eDHR) and asset capabilities. It lists ISO 13485, Part 820 and QMSR alignment. | Determine whether SaMD design controls and software lifecycle records are sufficiently connected for your product, and assess implementation resources, configuration, validation workload and total cost. The platform’s enterprise orientation may be more than a startup needs. |
Matrix Quality reported pricing
Analytics Insight reported the following Matrix Quality prices on September 24, 2026. These are publisher-reported figures, not a vendor quote; confirm current availability and terms directly.
#1 Best Overall
| Plan | Reported price |
|---|---|
| Light | $15 per user per month |
| Plus | $45 per user per month |
| Full | $90 per user per month |
| Admin | $125 per user per month |
| Minimum annual deal size | €10,000 |
The published figures do not establish which modules, user types, services, taxes or contract conditions apply to a particular buyer. Request a written quote and model the three-year total, including implementation and internal validation work.
Four more platforms named on the 2026 shortlist
Ketryx, Scilife, SimplerQMS and Dot Compliance are named in the title-specific 2026 shortlist. The available supporting material does not establish enough platform-level detail to score or order these products against the same criteria as the four above. That is an evidence limitation, not a judgment about their quality.
Rank #2
- Ketryx: Confirm its current SaMD software-lifecycle coverage, design-control and risk traceability, validation documentation, implementation scope and pricing directly with the vendor.
- Scilife: Verify the modules available for ISO 13485/QMSR workflows, software lifecycle, validation evidence, implementation and current pricing.
- SimplerQMS: Verify its ISO 13485 and QMSR claims, Design Controls, risk-management workflows, validation artifacts and current commercial terms.
- Dot Compliance: Verify Part 11 and ISO 13485 coverage, SaMD software-lifecycle workflows, validation package, implementation claims and current pricing.
Do not treat their inclusion on a shortlist as proof that they meet a particular regulatory or technical requirement. Ask for demonstrations and written, product-specific responses to the same RFP questions used for the other candidates.
What SaMD buyers should require from an eQMS
Design history and software-development traceability
Check whether design inputs, outputs, reviews, verification, validation, transfer and design changes can be linked to one another and to the relevant risk records. The practical question is not simply whether a platform has a “Design Controls” module; ask to see how a requirement, its verification evidence, a related hazard and a later change remain connected in the record.
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ISO 14971 support matters when hazard analyses, risk controls and residual-risk evaluations must remain traceable through design changes, complaints and corrective and preventive action (CAPA). Ask vendors to demonstrate these links using a realistic SaMD change scenario, rather than showing risk records in isolation.
Core quality workflows
Compare how each candidate supports document control, training, supplier controls, audits, nonconformance, complaints, deviations and CAPA. A software medical-device team should test whether records can be routed, approved, retrieved and linked without building a parallel spreadsheet or document trail for product-specific work.
Validation evidence and audit trails
Ask for the validation package and define what your organization must do to establish that the configured system is fit for its intended use. The practical artifacts identified in the comparison guidance include a user requirements specification (URS), risk assessment, installation/operational/performance qualification (IQ/OQ/PQ) evidence and audit-trail documentation. Also review change control: updates to the eQMS may affect your validated state and procedures.
Implementation, residency and cost
The available comparison does not provide comparable figures for regional data residency, implementation time, internal validation workload or three-year total cost across all eight products. Ask each vendor to state these in writing for your intended deployment and configuration. Include subscription or license charges, implementation, integrations, migration, training, support, additional modules and the staff time needed to validate and maintain the system.
Best Value
FDA QMSR and eQMS validation: what changed in 2026
FDA’s revised Quality Management System Regulation (QMSR), under 21 CFR Part 820, took effect on February 2, 2026. It incorporates ISO 13485:2016 by reference; FDA says the ISO 13485 requirements, taken together, are substantially similar to the former Quality System regulation requirements. SaMD companies selling into the United States should evaluate their quality system against the current QMSR, rather than treating the former QS regulation as the current baseline.
The eQMS itself is software used in the quality system, so the organization must validate it for its intended use. Buying a product marketed as “validated,” “validation-ready” or “compliant” does not transfer that responsibility. FDA’s February 2026 Computer Software Assurance guidance describes a risk-based approach to establishing confidence in software used in medical-device production or the quality management system. Use the system’s documentation as evidence, then determine and document the assurance appropriate to your use and risks.
These regulatory points are based on FDA’s QMSR explanatory material and its February 2026 Computer Software Assurance guidance. They are not a substitute for assessing your specific products, markets and quality-system obligations.
How to shortlist and compare vendors
- Map your product and markets. Identify whether your organization is developing SaMD, connected devices or both, where products will be marketed, and which quality processes must be in scope.
- Prepare a traceability demonstration. Ask every candidate to show a design requirement through review, verification or validation evidence, risk control, approval and a later change.
- Review validation and change-control materials. Request the available URS, risk assessment, IQ/OQ/PQ materials, audit-trail documentation and procedures or evidence for product updates. Establish what your team must author, execute and retain.
- Compare everyday workflows. Use representative scenarios for a complaint, nonconformance, CAPA, supplier issue, training assignment and controlled document change. Record manual steps and disconnected records.
- Get a written deployment and cost proposal. Ask for implementation scope and schedule, migration and integration assumptions, regional data residency, support terms, validation effort and a three-year cost estimate.
- Verify the claims before selection. Match each response to the edition and configuration being quoted, and make regulatory, validation and service commitments explicit in the contract or implementation statement of work where appropriate.
Source basis and limits
Regulatory statements above draw on FDA’s QMSR explanatory material and the FDA Computer Software Assurance guidance dated February 2026. Platform descriptions draw on the ISO 13485 comparison source; Matrix Quality’s listed prices and modules are reported by Analytics Insight in a comparison dated September 24, 2026. The shortlist names eight platforms, but supporting feature-level evidence is not available here for Ketryx, Scilife, SimplerQMS or Dot Compliance. No comparable price, implementation-time or data-residency figures are established for the full group.
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