The best QMS software for medical devices, ranked for your company

What QMS software needs to do for medical devices

A quality management system is the set of processes your company runs: document control, training, design controls, risk management, supplier control, CAPA, complaints and audits. QMS software (often called eQMS software) gives those processes a home, with approvals, signed records and links between them. It doesn’t make you compliant. An auditor checks that your processes meet the requirements and that your team follows them, and a tool can make that easier or harder to show.

These are the requirements a medical device QMS software should support:

• ISO 13485:2016. The international standard for quality management systems in the design and manufacture of medical devices. ISO last reviewed and confirmed it in 2025, so the 2016 edition is still current.¹
• FDA QMSR. The amended 21 CFR Part 820, now titled the Quality Management System Regulation, took effect on 2 February 2026. It incorporates ISO 13485:2016 by reference.² One ISO 13485-based process set now underpins both the EU and US.
• 21 CFR Part 11. Part 11 applies to records kept electronically under FDA record requirements. It sets the criteria under which electronic records and signatures count as equivalent to paper records and handwritten signatures.³
• EU MDR. Article 10(9) requires manufacturers to run a QMS that covers at least 13 aspects, including risk management, clinical evaluation, product realisation, UDI verification, post-market surveillance, vigilance reporting and CAPA.⁴ Article 83 makes the post-market surveillance system part of that QMS.⁴
• ISO 14971 and IEC 62304. ISO 14971:2019 sets out risk management for the whole device life cycle, including software as a medical device.⁵ IEC 62304 (edition 1.1, 2015) defines life cycle requirements for medical device software.⁶ The MDR requires device software to follow the state of the art for development life cycle, risk management, information security, and verification and validation.⁴

Coverage varies more than vendor pages suggest. In our clause matrix, all 15 systems support electronic signatures, but only five fully cover the IEC 62304 software lifecycle and none fully covers UDI management.⁷ Only one fully covers FDA and EU regulatory reporting.⁷ Check the matrix on each review for the clauses you’ll be audited on.

When you need QMS software, and what to prioritise

The sentence at the top of this page re-sorts the ranking by team size, product type and goal. Here is what each stage usually calls for.

Pre-certification startup (1–10 people). You need templates, a short setup and a low fixed cost more than configurable workflows. Favour systems you can try yourself, on short contracts, with a documented export, so an early choice doesn’t lock you in. Pick “1–10 people” and “our first ISO 13485 certificate” above.

First audit or FDA submission. Now the records matter: signed approvals, training records, a design history file and a risk file that link to each other. Ask what validation documentation the vendor provides, because you’ll need to show the system works for your use. Choose “our first ISO 13485 certificate” or “FDA clearance”.

Scaling (10–50 people and beyond). Per-user pricing starts to dominate, and complaints, suppliers and internal audits get busier. Check how the price grows with seats and whether you can reduce licences later. Pick “10–50 people” or “200+ people”.

Replacing an eQMS. Your exit from the current vendor shapes the project: notice periods, export formats and any export fees. Pick “to replace our current eQMS”, and read the contract section of your current vendor’s review before you give notice.

Product type changes the order too. Software (SaMD) teams need traceability from requirements to risks and tests, ideally linked to Jira or Git; physical-device makers need supplier control, production records and complaints; device-and-pharma companies need GMP workflows as well.

What QMS software costs

Five of the 15 vendors publish a price we can use for a 10-person team:

• Formwork: 499 € a month for unlimited users, about $7,000 a year.⁸
• Cognidox: from £6,000 a year (about $8,000) for up to 5 users, without e-signatures.⁹
• Greenlight Guru: eQMS packages “start at $12,000 per year”, users and modules not stated.¹⁰
• SimplerQMS: from $17,500 a year for up to 15 users, including implementation and validation.¹¹
• Matrix Requirements: about $21,800 a year at list prices for Matrix Req plus ten Matrix Quality licences.¹²¹³

For four more, we estimated a 10-person cost from archived prices, benchmarks and public contracts: Arena QMS at $12–25k,¹⁴ Qualio at $12–30k,¹⁵ Ideagen Quality Management at $22–29k¹⁶ and MasterControl at $25–72k a year.¹⁷¹⁸ The other six publish no usable price. The only public figures are floors: a directory listing puts Dot Compliance from $10,000 a year,¹⁹ Qualityze lists $30 per user per month for its lowest licence type,²⁰ and Ketryx offers a free plan only to pre-market companies that raised under $2 million.²¹

Entry prices understate what buyers pay. Vendr reports Greenlight Guru deals from $20,975 to $54,739 a year,²² and a current customer wrote in 2026 that “the cost is starting to hurt a bit as the team grows.”²³

Hidden costs to ask about

• Implementation. Greenlight Guru quotes it separately,¹⁰ every Qualio plan carries an unpublished implementation fee,¹⁵ and Ideagen charges £1,330 a day.¹⁶ Vendr puts Arena implementations at $15,000–50,000.¹⁴ SimplerQMS includes implementation in the subscription.¹¹
• Validation packs. Ideagen sells an IQ/OQ pack for £4,000 and an IQ/OQ/PQ pack for £9,320.¹⁶ Cognidox lists its validation pack as an unpriced add-on.⁹ Greenlight Guru includes validation documentation for every release.¹⁰
• Renewal increases. SimplerQMS adds 5% to all prices every 1 January,²⁴ and Octave’s ETQ Reliance contract allows up to 7% a year.²⁵ Arena, Ketryx, Matrix One and MasterControl set no cap.^26272829 Matrix Req list prices rose about 31–33% from 2023 to 2026,³⁰³¹ and Cognidox’s per-user prices rose 17–20% from 2025 to 2026.³²³³
• Contract length and seats. Ideagen’s standard agreement runs 24 months, renews automatically, and doesn’t let you cut licences below half of the previous fees.³⁴ MasterControl doesn’t let you reduce licences during a term.²⁹
• Exit fees. After an Arena contract ends, its one-time export is “subject to then-current professional services fees”.²⁶ Ideagen charges extra for large exports and deletes data after termination.³⁵³⁴ By contrast, SimplerQMS says its exit export costs nothing extra,¹¹ and Greenlight Guru says you can export records in standard formats without paying for services.¹⁰

How to compare QMS software vendors

Our ranking method scores twelve criteria. Seven of them are buying questions you can check yourself in a demo. Ask each vendor the same questions, and get the answers in writing.

The answers differ a lot. Ketryx offers a self-serve 30-day trial without a credit card,³⁶ and Matrix Req a self-serve trial too,³⁷ while Greenlight Guru, Qualio, MasterControl, Ideagen, ETQ, Orcanos and Qualityze offer no free trial.^{38394041424344} Qualio hosts its web application on AWS in Dublin,⁴⁵ and Arena runs a separate European instance,⁴⁶ while MasterControl’s subprocessor list gives the hosting location as “Global”.⁴⁷ Put two shortlisted systems side by side in our head-to-head comparisons.

Where to start

Scores below are our overall scores out of 10; the ranking above weighs them by fit for your situation.

Software-heavy devices. Matrix Requirements (7.5) links requirements, risks and tests to Jira, Git and Azure DevOps, but a full QMS needs a second product, Matrix Quality.⁴⁸ Ketryx (6.5) generates the design history file from Jira and Git work, but we found no supplier or internal audit workflows, so most teams run it next to another eQMS.⁴⁹ Orcanos (6.4) traces requirements, risk, tests and QMS records in one system, without public prices.⁴³

First certification on a small budget. Formwork (7.6) has a flat price and templates, but we found no complaint handling, internal audit planning or vigilance features.⁸ Cognidox (7.2) is strong on document control with Part 11 signatures, but complaints, supplier, audit and design controls are largely document- or form-based.⁵⁰ SimplerQMS (7.1) bundles implementation, validation and training, but manages design controls and risk as documents.⁵¹

Physical devices with design controls and risk in one place. Greenlight Guru (7.4) links design controls, ISO 14971 risk and quality events in a MedTech-only system, at a price well above its entry figure.³⁸ Arena QMS (6.6) ties quality records to the bill of materials and change orders, but has no risk-management or IEC 62304 features.⁵²

Multi-site and device-and-pharma companies. MasterControl (5.3), ETQ Reliance (5.3) and Qualityze (5.1) are configurable systems for documents and CAPA across sites. They score lower on price transparency and design controls.⁴⁰⁴²⁴⁴ Scilife (6.3) and Dot Compliance (5.9) also suit combined device and pharma operations.⁵³⁵⁴

EU hosting. Qualio (6.8) and Arena QMS publish a DPA and subprocessor list and host in the EU.^45553952 SimplerQMS lets you choose EU or US hosting.⁵¹