# Best design control software for medical devices (2026)

Source: https://bestqmssoftware.com/design-control-software/
By Tom Muller, updated October 5, 2026
Part of Best QMS Software (https://bestqmssoftware.com/). Method: https://bestqmssoftware.com/how-we-rank/


## What design controls require

ISO 13485 clause 7.3 sets out design and development for medical devices: planning, design inputs, design outputs, design reviews, verification, validation, design transfer, control of design changes, and a design and development file that holds the records for each device.[^iso13485] The FDA's Quality Management System Regulation (QMSR) has incorporated ISO 13485:2016 by reference since 2 February 2026, so the same structure applies in the US.[^qmsr]

Two standards sit next to it. ISO 14971:2019 sets out risk management for the whole device life cycle, including software as a medical device.[^iso14971] It expects a risk management file in which each hazard can be traced to its risk analysis, risk controls and the verification of those controls.[^iso14971] IEC 62304 (edition 1.1, 2015) defines life cycle requirements for medical device software, scaled by a software safety class.[^iec62304] In the EU, Annex I Section 17.2 of the MDR requires device software to follow the state of the art for development life cycle, risk management, information security, and verification and validation.[^mdr]

In practice this is a traceability problem. Every user need should lead to design inputs, outputs and tests, and every hazard to a risk control and to the test that shows the control works. When a requirement changes, you need to see which risks and tests it touches.

## What to look for in design control software

- **Linked records, not linked documents.** Requirements, risks and tests should be items with trace links, so the system can show a missing test or an orphaned risk control. A folder of Word files with a trace matrix template is document control, not design control.
- **Risk inside the design.** Hazards, hazardous situations and harms as records, with risk controls that are themselves requirements and get verified.
- **Change impact.** Flags on linked items when something upstream changes, and versioned baselines per release.
- **IEC 62304 features** if you build software: safety class per product, software items, SOUP tracking, and traceability from software requirements to tests and risk controls.
- **Engineering tool links.** If your developers work in Jira, GitHub, GitLab or Azure DevOps, check which integrations are documented and which cost extra.
- **Generated outputs.** The trace matrix, risk management file and design history file should come out of the data, not be assembled by hand before each audit.

## Common gaps we found

**Documents dressed as design controls.** In several systems, design control means organising documents. SimplerQMS groups the design history file and technical file as document collections, with risk files and the trace matrix as controlled documents.[^r-simplerqms] Cognidox uses Document Holders as phase gates.[^r-cognidox] MasterControl's design pages describe managing design control, DHF and DMR documents.[^r-mc] Qualityze's design control module isn't released yet.[^r-qualityze] Ideagen's design controls appear only on a marketing page.[^r-ideagen]

**Risk not linked to design.** Scilife's risk module supports only FMEA for processes, equipment and systems, and risk items don't exist in its design module.[^r-scilife] Arena has requirement trace links but no documented link from requirements to risks or tests.[^r-arena] Ideagen's and Qualityze's documented risk modules are general risk registers.[^r-ideagen][^r-qualityze]

**Thin IEC 62304 support.** Qualio's design controls documentation doesn't cover software safety classes, software items or SOUP lists.[^r-qualio] Only five of the systems we had reviewed by October 2026 fully cover the IEC 62304 software lifecycle; for the rest, support is generic, a marketing claim, or not found.[^matrix]

**Generated files that are claimed, not shown.** Greenlight Guru says you can generate trace matrices, the DHF and the risk file, but we found no documentation showing it.[^r-gg] Scilife says you export and compile the design history file yourself.[^r-scilife]

**Integrations as add-ons or workarounds.** Qualio includes Jira but sells GitHub, GitLab and Azure DevOps links through its Integration Hub add-on.[^r-qualio] Orcanos connects Jira through Zapier.[^r-orcanos] Formwork has no development-tool integration.[^r-formwork]

## How we ranked design control software

The list below uses three rows of our clause matrix: design and development, risk management file (ISO 14971) and software lifecycle (IEC 62304). 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, document-based or only named on a marketing page.[^method] Systems with the same coverage are ordered by their overall score, which also includes our design controls criterion for traceability, engineering tool integrations and generated files.[^design] Our [ranking method](/how-we-rank/) explains every criterion.

[^iso13485]: [ISO 13485:2016 Medical devices: Quality management systems: Requirements for regulatory purposes](https://www.iso.org/standard/59752.html), clause 7.3. ISO, checked 1 Oct 2026.
[^qmsr]: [FDA: Quality Management System Regulation (QMSR)](https://www.fda.gov/medical-devices/postmarket-requirements-devices/quality-management-system-regulation-qmsr). FDA, updated 2 Feb 2026, checked 1 Oct 2026.
[^iso14971]: [ISO 14971:2019 Medical devices: Application of risk management to medical devices](https://www.iso.org/standard/72704.html). ISO, checked 1 Oct 2026.
[^iec62304]: [IEC 62304:2006+AMD1:2015 CSV](https://webstore.iec.ch/en/publication/22794). IEC Webstore, checked 1 Oct 2026.
[^mdr]: [Regulation (EU) 2017/745 on medical devices](https://eur-lex.europa.eu/eli/reg/2017/745/oj), Annex I Section 17.2. EUR-Lex, checked 1 Oct 2026.
[^r-simplerqms]: [SimplerQMS review](/reviews/simplerqms/), features section, checked 4 Oct 2026.
[^r-cognidox]: [Cognidox review](/reviews/cognidox/), features section, checked 4 Oct 2026.
[^r-mc]: [MasterControl review](/reviews/mastercontrol/), features section, checked 4 Oct 2026.
[^r-qualityze]: [Qualityze review](/reviews/qualityze/), features section, checked 4 Oct 2026.
[^r-ideagen]: [Ideagen Quality Management review](/reviews/ideagen-quality/), features section, checked 4 Oct 2026.
[^r-scilife]: [Scilife review](/reviews/scilife/), features section, checked 4 Oct 2026.
[^r-arena]: [Arena QMS review](/reviews/arena-qms/), features section, checked 4 Oct 2026.
[^r-qualio]: [Qualio review](/reviews/qualio/), features section, checked 4 Oct 2026.
[^r-gg]: [Greenlight Guru review](/reviews/greenlight-guru/), features section, checked 4 Oct 2026.
[^r-orcanos]: [Orcanos review](/reviews/orcanos/), features section, checked 4 Oct 2026.
[^r-formwork]: [OpenRegulatory Formwork review](/reviews/formwork/), features section, checked 4 Oct 2026.
[^matrix]: Clause matrix across our [reviews](/reviews/), data as of 4 Oct 2026.
[^method]: [How we rank QMS software: compliance coverage](/how-we-rank/#compliance).
[^design]: [How we rank QMS software: design controls and traceability](/how-we-rank/#design).


## Ranking

1. [OpenRegulatory Formwork](https://bestqmssoftware.com/reviews/formwork/): Design and development documented; Risk management file documented; Software lifecycle documented. $7k/yr. Requirements link to failure modes, risk controls and tests, each product records its IEC 62304 safety class, and an audit export produces trace matrices per release, but there's no Jira or Git integration (the vendor says by design) and no REST API.
2. [Matrix Requirements (Matrix One)](https://bestqmssoftware.com/reviews/matrix-requirements/): Design and development documented; Risk management file documented; Software lifecycle documented. from $22k/yr. Traceability rules per category flag broken or outdated links, the risk module exports FMEA tables, and Jira, GitHub, GitLab and Azure DevOps connect natively, but the IEC 62304 template package is only on the Company and Enterprise plans.
3. [Greenlight Guru](https://bestqmssoftware.com/reviews/greenlight-guru/): Design and development documented; Risk management file documented; Software lifecycle documented. from $12k/yr. A design control matrix links user needs, inputs, outputs, verification and validation, with an ISO 14971 risk matrix and Jira and GitHub references, but the generated DHF, trace matrix and risk file are claimed without documentation we could check.
4. [Orcanos](https://bestqmssoftware.com/reviews/orcanos/): Design and development documented; Risk management file documented; Software lifecycle documented. Pricing on request. The ISO 14971 FMEA runs from hazard to mitigation to verification test, the risk file and design documents generate to Word, and IEC 62304 checks use the software safety class, but Jira connects only through Zapier and GitHub and Azure DevOps links aren't documented.
5. [Ketryx](https://bestqmssoftware.com/reviews/ketryx/): Design and development documented; Risk management file documented; Software lifecycle documented. Pricing on request. Requirements, software items, tests and risks sync from Jira, Git and test tools into a generated DHF, trace matrix and risk file, with SOUP tracked through a software bill of materials, but Ketryx describes itself as a bridge between engineering tools and an existing eQMS.
6. [Qualio](https://bestqmssoftware.com/reviews/qualio/): Design and development documented; Risk management file documented; Software lifecycle partly. est. $12–30k/yr. Up to three requirement levels link to verification and validation tests and to ISO 14971 risk, with generated trace matrices, but there are no software safety classes or SOUP lists, and GitHub, GitLab and Azure DevOps need the paid Integration Hub add-on.
7. [Arena QMS](https://bestqmssoftware.com/reviews/arena-qms/): Design and development documented; Risk management file partly; Software lifecycle partly. est. $12–25k/yr. Requirements trace to other requirements and to items, with suspect flags when something upstream changes, and users build the DHF in Projects, but there's no documented link from requirements to risks or tests and no risk register or IEC 62304 features.
8. [Scilife](https://bestqmssoftware.com/reviews/scilife/): Design and development documented; Risk management file partly; Software lifecycle partly. Pricing on request. The Design and Development module (since 2025) links user needs through to verification and validation in a matrix that flags unlinked items, but risk is an FMEA for processes and equipment that isn't linked to design items, and you compile the DHF yourself.
9. [Cognidox](https://bestqmssoftware.com/reviews/cognidox/): Design and development partly; Risk management file partly; Software lifecycle partly. from $8k/yr. Document Holders act as phase gates that can't be approved until every document in them is, but traceability is only claimed on a product page, and we found no risk register, ISO 14971 tool or IEC 62304 features.
10. [SimplerQMS](https://bestqmssoftware.com/reviews/simplerqms/): Design and development partly; Risk management file partly; Software lifecycle partly. from $17.5k/yr. The design module groups the DHF, DMR and technical file as document collections, and risk files and the trace matrix are controlled documents, with no linked requirements, risks or tests.
11. [Qualityze](https://bestqmssoftware.com/reviews/qualityze/): Design and development partly; Risk management file partly; Software lifecycle partly. Pricing on request. There's no design control module yet (it's planned for Release 17.0 with FMEA), the risk module is a general risk register, and IEC 62304 support is only a marketing claim.
12. [Ideagen Quality Management](https://bestqmssoftware.com/reviews/ideagen-quality/): Design and development partly; Risk management file partly; Software lifecycle not found. est. $22–29k/yr. Design controls, design history files and ISO 14971 risk management are promised on a marketing page but don't appear in the help centre, where the risk module is a general business risk register.
13. [QT9 QMS](https://bestqmssoftware.com/reviews/qt9-qms/): Design and development partly; Risk management file partly; Software lifecycle not found. Pricing on request. Design control templates, phases and DHFs built from linked records are described only on a marketing page, risk assessments and FMEA calculate risk scores, and we found no requirement-to-risk-to-test links, IEC 62304 features or Jira integration.
14. [Dot Compliance](https://bestqmssoftware.com/reviews/dot-compliance/): Design and development partly; Risk management file partly; Software lifecycle not found. Pricing on request. A Design Control module exists but its manual is customer-only, FMEA with hazard traceability is described only on product pages, and we found no documented trace from requirements to risks to tests.
15. [ZenQMS](https://bestqmssoftware.com/reviews/zenqms/): Design and development partly; Risk management file partly; Software lifecycle not found. Pricing on request. There's no design-control module, only a configured change-control workflow with an imported trace matrix, risk assessments and FMEA appear only as examples of custom workflows, and ZenQMS's own comparison page calls its device design-control support limited.
16. [TrackWise Digital](https://bestqmssoftware.com/reviews/trackwise/): Design and development not found; Risk management file documented; Software lifecycle not found. Pricing on request. There are no design controls, requirements traceability or IEC 62304 features, but a separate risk module keeps an ISO 14971 risk file per product with hazard analysis, FMEA and a residual-risk matrix linked to nonconformances and CAPAs.
17. [ETQ Reliance (Octave Reliance)](https://bestqmssoftware.com/reviews/etq-reliance/): Design and development partly; Risk management file partly; Software lifecycle not found. Pricing on request. There's no design controls app, only APQP project control, specifications and an FMEA with a hazard analysis, with no ISO 14971 risk management file or DHF export.
18. [MasterControl](https://bestqmssoftware.com/reviews/mastercontrol/): Design and development partly; Risk management file partly; Software lifecycle not found. est. $25–72k/yr. Development Excellence manages design control, DHF and DMR documents rather than linked requirements and tests, and the risk module describes no ISO 14971 risk file.