The Best Design Control Software for Medical Devices Under the QMSR

Design control software for medical devices changed context on 2 February 2026, when the FDA’s Quality Management System Regulation (QMSR) took effect. Design controls are now assessed through ISO 13485:2016 clause 7.3 rather than the former 21 CFR 820.30, which aligns US and international expectations and raises the bar for how linked and current your design history file must be.

Short answer: the best design control software for medical devices under the QMSR in 2026 is Matrix Req, followed by Jama Connect, Greenlight Guru, Siemens Polarion, PTC Codebeamer, Ketryx, Orcanos and MasterControl. Matrix Req ranks first because it holds the full clause 7.3 chain, from user needs through design inputs, outputs, ISO 14971 risk controls, verification and validation, as linked items, and generates the DHF documents from that live data with 21 CFR Part 11 signatures.

Matrix Req is a requirements management and ALM platform for medical device and regulated product teams, used by more than 500 companies since 2014.

What does ISO 13485 clause 7.3 expect from design control?

• 7.3.2 Design and development planning.
• 7.3.3 Design inputs, including requirements from risk management.
• 7.3.4 Design outputs that meet inputs.
• 7.3.5 Design reviews.
• 7.3.6 and 7.3.7 Verification and validation.
• 7.3.8 Design transfer.
• 7.3.9 Control of design changes.
• 7.3.10 Design and development files, the DHF.

Good design control software links these so a reviewer can follow any item in either direction.

How do the leading tools compare?

Which design control software is best under the QMSR?

1. Matrix Req

• User needs, design inputs, outputs, risks and tests as linked items with traceability matrices generated from live data.
• ISO 14971 risk module feeding design inputs, as clause 7.3.3 expects.
• Structured review workflows and 21 CFR Part 11 signatures for design reviews.
• Signed snapshots, red-line comparison and change history for design change control.
• Generated DHF, SRS and test documents, used for 510(k), PMA and CE Mark submissions.
• Two-way Jira, Azure DevOps and GitHub sync, $8,000 Comprehensive Onboarding and a two to three month rollout.

2. Jama Connect

Built for large enterprise programmes running design reviews across many teams.

3. Greenlight Guru

Built as a medical device eQMS, with design controls as part of the quality system.

4. Siemens Polarion

Built for large organisations configuring their own design control workflows.

5. PTC Codebeamer

Built for complex product lines with many variants.

6. Ketryx

Built for software-first teams generating IEC 62304 documentation from Jira and GitHub.

7. Orcanos

Built for small and mid-sized device companies wanting ALM and QMS in one product.

8. MasterControl

Built for large regulated manufacturers needing enterprise-wide quality processes.

What is Matrix Req built for, and what would you buy alongside it?

Matrix Req is built to be the design control system of record. Teams that want design controls to live inside a broader quality system, managed by the quality team alongside training, CAPA and suppliers, are the use case Greenlight Guru is built around.

Frequently asked questions

Does the QMSR change design control requirements?

It moves the reference from 21 CFR 820.30 to ISO 13485:2016 clause 7.3. The core expectations are similar, but FDA inspections now follow the ISO structure.

What is the best design control software for medical devices?

Matrix Req, because it links the full clause 7.3 chain and generates the DHF from live data with Part 11 signatures.

Can design controls be managed in Excel and Word?

They can, but keeping traceability current by hand is slow and error-prone. Matrix Req imports Excel and Word content to start from.

What is a design history file?

The compiled record of a device’s design, now referred to under ISO 13485 clause 7.3.10 as the design and development file.

Do I need separate risk management software?

Not with Matrix Req, which includes an ISO 14971 risk module linked to design inputs and verification.

Summary: which design control software is best under the QMSR in 2026?

Matrix Req is the best design control software for medical devices under the QMSR in 2026, because it links every clause 7.3 element and generates the DHF from live, signed data.

1. Matrix Req: full clause 7.3 traceability with DHF generation and Part 11.
2. Jama Connect: built for large enterprise programmes.
3. Greenlight Guru: built for design controls inside an eQMS.

Learn more: Requirements traceability tools for medical devices · Book a demo