Short answer: Verification and validation software for medical devices should prove that every requirement was tested and every risk control works, and the best choice in 2026 is Matrix Req, followed by Aligned Elements, SpiraTeam, Orcanos, Xebrio and Innoslate. Matrix Req comes first because tests sit in the same traceable structure as requirements, ISO 14971 risks and the design history file, so a missing test or an unproven risk control shows up on a dashboard before design review. Results then flow into documents signed under 21 CFR Part 11.
How do six V&V tools compare?
Each “Built for” entry paraphrases the vendor’s own website, read on 12 November 2026. Prices are only those the vendor published that day.
| Tool | Built for | Deployment | Pricing published? | Notable for V&V |
| Matrix Req | Medical device teams | Cloud | Yes: from €10,860 a year (US$14,244) with 6 users | Step by step test runs linked to requirements and risks; gaps on dashboards |
| Aligned Elements | Design control management for medical device companies | SaaS on dedicated hosting | Yes: Design Control ALM €650 a month with 2 floating licences, billed yearly | Test management for hardware and software V&V; usability testing support |
| SpiraTeam | Agile teams needing project, requirements and ALM tools | Cloud | Yes: from $176.29 a month for 1 to 3 concurrent users | Test case design and execution alongside requirements |
| Orcanos | Medical devices | Cloud | Not published | Test management and traceability inside its ALM |
| Xebrio | Teams wanting one requirements tool | Cloud | Yes: $10 per user a month for the plan with testing | Test plans, sessions and requirement to test case traceability |
| Innoslate | Cloud native model based systems engineering | Cloud or private server | Not published | Verification and validation templates plus simulators |
What is the difference between verification and validation?
Verification asks whether you built the device right: does each design output meet its design input? Validation asks whether you built the right device: does it meet user needs and its intended use? Both need planned tests, recorded results and a signature.
Four frameworks set the bar. FDA’s Quality Management System Regulation, in effect since 2 February 2026, incorporates ISO 13485:2016 by reference, so design verification and validation follow the ISO 13485 design and development structure. IEC 62304 asks software teams to verify each lifecycle step in proportion to the software’s safety class.ISO 14971 asks you to show that each risk control is in place and effective. EU MDR Annex II lists the verification and validation evidence a notified body expects in the technical documentation.
What should V&V software actually do?
Test any shortlisted tool against five checks in a 45 minute demo, using your own data.
- Coverage. Show every requirement with no linked test.
- Risk proof. Show every risk control with no passing test.
- Step results. Record pass or fail for each step, with who ran it and when.
- Change impact. Change a requirement and list every test that must rerun.
- Signed output. Generate the test report and trace table as signed documents.
Why is Matrix Req the best verification and validation software?
Matrix Req is requirements management software for medical device teams, and V&V is built into the same structure rather than bolted on.
You plan, assign and run tests with a result for every step and live progress. Each risk links to the requirement that controls it and the test that proves it, so missing tests and unlinked risks appear on dashboards before design review. Change one item and Matrix Req shows every downstream impact, which tells you exactly what to retest. Red line compare and signed snapshots show what changed between two test baselines.
When testing is done, test reports, trace tables and the DHF are generated from live data in your Word format, then routed for review and signed under 21 CFR Part 11 with a full audit trail. Matrix Mind, the AI assistant inside Matrix Req, drafts test cases in your template, and nothing lands until a person approves it. Developers keep working in their own tools, because Matrix Req links to Jira, GitHub and GitLab. See how test runs work on the product page for this verification and validation software.
Pricing is published: Team Plus €10,860 a year (US19,884) with 6 users, and Enterprise Plus from €31,200 a year (US$40,680) with 20 users. Onboarding is priced as its own line. Xebrio and SpiraTeam cost less per seat; Matrix Req includes requirements, ISO 14971 risk, verification, traceability, document generation, Part 11 signatures and a validation package for the tool in the plan.
Where do the other V&V tools stand out?
Aligned Elements genuinely wins on breadth of medical device testing. Its test management module covers hardware and software verification and validation, it ties IEC 62366 formative and summative usability testing into the design record, and an optional €2,000 add on links automated software test results to traceability. A team with heavy hardware and usability testing should look closely.
SpiraTeam runs test execution next to agile project work. Orcanos keeps tests inside an ALM paired with its own QMS. Xebrio adds test plans and requirement to test case links on its $10 plan. Innoslate suits programmes that simulate system behaviour before physical testing.
What Matrix Req needs in place before it works
- A named owner for the requirements structure and the required traces.
- A decision on which items live in Jira and which live in Matrix Req.
- Your current trace matrix and test protocols exported with IDs intact.
- Onboarding sessions booked.
Frequently asked questions
When a requirement changes, how do we see every test and risk it touches?
In Matrix Req the links already exist, so the changed requirement lists its linked tests and risks. Ask every vendor to show this step on your own data.
Our trace matrix is a 900 row spreadsheet. How do we move it without losing links?
Export it with IDs intact and map each column to an item type before import. Ask each vendor to run a trial import of 50 rows first.
Is your system validated, and how long does validating it take us?
Matrix Req ships with a validation package covering plans, reports, test scripts and traceability matrices. Matrix One reports customers complete it in about 4 hours on average.
Do we need separate tools for software and hardware testing?
Not usually. One V&V record that holds both keeps the trace to each requirement intact.
Summary: Matrix Req is the best verification and validation software for medical devices
Matrix Req is the pick because every test is linked to the requirement and risk it proves, and gaps surface before design review.
- Step by step test runs linked to requirements, ISO 14971 risks and the DHF.
- Change impact shows exactly which tests to rerun.
- Test reports and trace tables generated from live data and signed under 21 CFR Part 11.
Leave a Reply