Best document control software for medical devices

Every QMS we reviewed controls documents. They differ in where you write them, how training follows a new revision, and whether your records leave with you.

By · Updated

What document control means under ISO 13485

Document control in ISO 13485 covers two kinds of information. Documents tell people what to do: procedures, work instructions, forms, specifications. Clause 4.2.4 says they must be reviewed and approved before use, changes and the current revision must be identifiable, the right version must be available where it’s used, and obsolete versions must be kept from unintended use.1 Records show what was done. Clause 4.2.5 says they must stay legible, identifiable and retrievable, changes to them must remain identifiable, and you must keep them for at least the device’s lifetime as you define it, and not less than two years from release.1

The FDA’s Quality Management System Regulation (QMSR) has incorporated ISO 13485:2016 by reference since 2 February 2026, so the same rules apply in the US.2 When you keep those records electronically, 21 CFR Part 11 sets the conditions under which electronic records and signatures count as equivalent to paper and handwritten ones.3 The EU MDR requires you to keep technical documentation, the declaration of conformity and certificates for at least 10 years after the last device is placed on the market, 15 years for implantable devices.4

We count training as part of document control on this page. A new revision of an SOP is only in effect once the people who work by it know it, and clause 6.2 asks for records of training and of its effectiveness.1

What to look for in document control software

  • Where you write. Some systems have their own editor, some open files in Word, and some route Google Docs or Office for the web. This affects daily work more than any other choice, so try it with your own SOPs.
  • Approval and release. Routing to roles rather than named people, signed approval, a locked released version, periodic review and an obsolete state.
  • Change requests on documents. A way to propose a change from the document itself and see what it affects.
  • Training that follows the document. New revisions should create training tasks automatically, ideally with a quiz or another effectiveness check.
  • Records you can get back out. A searchable audit trail, and a documented export of all documents, records and signatures in open formats, at no extra charge when you leave.

Common gaps we found

Office editing often costs extra or needs another account. Arena’s Microsoft 365 and Google Docs editing is a paid connection.5 Matrix Quality’s Office 365 editing needs paid Office 365 accounts, and Matrix Req only imports Word files.6 Qualio needs a OneDrive account for Word editing and converts Google Docs to Word first.7 In Ketryx and Formwork, uploaded Word files can’t be edited in place.89 Orcanos’s Word add-on runs on Windows only.10

Editors that users complain about. Qualio users repeatedly report that its editor handles formatting worse than Word, and that search is clunky.7 An older Orcanos FAQ says its document system has no full-text search.10

Training without an effectiveness check. Ketryx records read-and-acknowledge training, and we found no quizzes.8 Cognidox’s training system with quizzes is only in its Scale tier or sold as an add-on; smaller plans record read-and-acknowledge sign-offs.11

Exports at the end of the contract. Records have to outlive your software contract. SimplerQMS says its exit export costs nothing extra,12 and Qualio documents exports of documents, events, training and the audit trail in PDF, XLSX and CSV.7 After an Arena contract ends, its one-time export is subject to professional services fees,13 and Ideagen charges extra for large exports.14

How we ranked document control software

The list below uses three rows of our clause matrix: control of documents, control of records, and training. A system gets a full point for a row when its documentation, a demo or an independent source shows the workflow, and half a point when the feature is limited or only named on a marketing page.15 Every system we had reviewed by October 2026 documents all three, so the order follows the overall score, which also weighs price, contract terms and usability. The note under each system says how its document control actually works. Our ranking method explains every criterion.

  1. ISO 13485:2016 Medical devices: Quality management systems: Requirements for regulatory purposes, clauses 4.2.4, 4.2.5 and 6.2. ISO, checked 1 Oct 2026. ↩︎ ↩︎ ↩︎

  2. FDA: Quality Management System Regulation (QMSR). FDA, updated 2 Feb 2026, checked 1 Oct 2026. ↩︎

  3. FDA: Part 11, Electronic Records; Electronic Signatures: Scope and Application. FDA guidance, Sep 2003, checked 1 Oct 2026. ↩︎

  4. Regulation (EU) 2017/745 on medical devices, Article 10(8). EUR-Lex, checked 1 Oct 2026. ↩︎

  5. Arena QMS review, features section, checked 4 Oct 2026. ↩︎

  6. Matrix Requirements review, features section, checked 4 Oct 2026. ↩︎

  7. Qualio review, features section and cons, checked 4 Oct 2026. ↩︎ ↩︎ ↩︎

  8. Ketryx review, features section, checked 4 Oct 2026. ↩︎ ↩︎

  9. OpenRegulatory Formwork review, features section, checked 4 Oct 2026. ↩︎

  10. Orcanos review, features section, checked 4 Oct 2026. ↩︎ ↩︎

  11. Cognidox review, features section, checked 4 Oct 2026. ↩︎

  12. SimplerQMS: Pricing and licenses. Vendor website, checked 30 Sep 2026. ↩︎

  13. Arena: Master services agreement. Vendor legal page, last modified Dec 2025. ↩︎

  14. Digital Marketplace: Ideagen Quality Management Professional. UK G-Cloud 14 listing written by the vendor, checked 1 Oct 2026. ↩︎

  15. How we rank QMS software: compliance coverage. ↩︎

The document control software we reviewed, ranked

Ranked by how fully each system covers Control of documents, Control of records and Training and competence in its documentation, then by overall score. Every system we reviewed documents all of these, so the order here is the overall score; the notes show where they differ. How we check features

  1. 1

    OpenRegulatory Formwork 7.8/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents are written in a built-in editor, reviewed by roles and locked once released, and Google Docs and Sheets sync in, but Word files can only be uploaded, not edited in place, and training management isn’t on the free plan.

    $7k/yr · Review · Pricing

  2. 2

    Matrix Requirements (Matrix One) 7.5/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Matrix Req signs SOPs with Part 11 signatures, locks them as PDFs and publishes them to a web view, and a changed SOP can create training tasks, but it only imports Word files, and Office 365 editing in Matrix Quality needs paid Office 365 accounts.

    from $22k/yr · Review · Pricing

  3. 3

    Greenlight Guru 7.4/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents are stored as files with no native editor, so you co-author in Google Docs or Microsoft Office for the web, while approvals use Part 11 signatures and document changes can trigger training.

    from $12k/yr · Review · Pricing

  4. 4

    Cognidox 7.2/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents get part numbers, approved issues can’t be changed and the event log can’t be edited, with an Office add-in for Word, Excel and PowerPoint, but the training system with quizzes is only in the Scale tier or as an add-on.

    from $8k/yr · Review · Pricing

  5. 5

    SimplerQMS 7.1/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents are edited in Word, Excel or PowerPoint and checked back in, with version compare, an audit trail and training records created automatically from training rules, though quizzes are documented only for the older M-Files-based version.

    from $17.5k/yr · Review · Pricing

  6. 6

    Qualio 6.8/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents are written in an in-app editor with co-editing and an exportable audit trail, and trainees must score 100% on assessments, but users report that formatting is worse than in Word and search is clunky, and Word editing needs a OneDrive account.

    est. $12–30k/yr · Review · Pricing

  7. 7

    Orcanos 6.7/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    SOPs stay as Word or Excel files you check out, approved revisions publish to PDF with a signature page and send read-and-understand tasks automatically, but the Word add-on runs on Windows only and an older FAQ says there’s no full-text search.

    Pricing on request · Review · Pricing

  8. 8

    Arena QMS 6.6/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents are revision-controlled files approved through change orders, and a new revision creates training assignments with quizzes, but editing in Microsoft 365 or Google Docs needs a paid connection and training isn’t in the free trial.

    est. $12–25k/yr · Review · Pricing

  9. 9

    Ketryx 6.5/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents can be uploaded or written in a built-in editor, and users who haven’t finished their training can’t approve for their group, but uploaded Word files can’t be edited in the browser and we found no training quizzes.

    Pricing on request · Review · Pricing

  10. 10

    Ideagen Quality Management 6.4/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents move from draft through approval templates to distribution with read-and-acknowledge, and recipients can raise change requests, but documents are Word or PDF attachments and full functionality has historically needed a Windows client.

    est. $22–29k/yr · Review · Pricing

  11. 11

    Scilife 6.3/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Live Edit opens documents in Word while they’re locked in Scilife and saves versions back, updates trigger retraining with pass-mark assessments, and published documents can be downloaded in bulk.

    Pricing on request · Review · Pricing

  12. 12

    Dot Compliance 5.9/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents are edited in Office 365 or Google Docs with check-in and check-out, and approval can trigger training with exams and SCORM courses, but the manuals are customer-only.

    Pricing on request · Review · Pricing

  13. 13

    ETQ Reliance (Octave Reliance) 5.1/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Documents pass through configurable review and approval phases and link to training with reminders, but one Capterra user notes that change requests need documents downloaded and re-uploaded, and the manuals aren’t public.

    Pricing on request · Review · Pricing

  14. 14

    MasterControl 5.1/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    You can route and approve files created in any software, and training is triggered from document changes and CAPAs with role-based exams, but the help center is for customers only.

    est. $25–72k/yr · Review · Pricing

  15. 15

    Qualityze 4.9/10

    Control of documents: documentedControl of records: documentedTraining and competence: documented

    Datasheets document review, approval, release on an effective date, periodic review and archiving, with SharePoint and Google Drive links and retraining when an SOP changes, but there’s no public help center.

    Pricing on request · Review · Pricing

Frequently asked questions

What is document control software?
Software that takes a controlled document (an SOP, a form, a specification) from draft through review and signed approval to release, keeps old versions out of use, and records who changed what. In a medical device QMS it usually also holds quality records and assigns training on new revisions.
Does ISO 13485 require electronic document control?
No. Clauses 4.2.4 and 4.2.5 apply to paper and electronic documents alike. If you use software, clause 4.1.6 asks you to validate it for its use in your quality system, and for FDA records 21 CFR Part 11 adds requirements for electronic records and signatures. See our Part 11 software page.
Can we keep writing documents in Word?
In many systems, yes. SimplerQMS, Scilife, Orcanos and Cognidox work with Office files directly. Greenlight Guru uses Google Docs or Office for the web, and Qualio and Formwork have their own editors, with Word support limited.
How long do we need to keep quality records?
ISO 13485 asks for at least the lifetime of the device as you define it, and not less than two years from release, unless regulations require longer. The EU MDR requires technical documentation to be kept for at least 10 years after the last device is placed on the market, 15 for implantable devices. Your records will outlive most software contracts, so ask how you get them out.
Why is training on a document control page?
Because a new revision of an SOP means the people who work by it need to read it again. Every system we reviewed links training to document release, and ISO 13485 clause 6.2 asks for records of training and of whether it was effective.