Short answer: For a growing medical device team, start with one tool: Matrix Req, which holds requirements, ISO 14971 risk, verification and a light QMS (CAPA, document control, Part 11 e signatures, audit trail) in one traceable structure. Grow into Matrix Quality on the same Matrix One platform when training, suppliers and change control need a full eQMS. Orcanos, Aligned Elements, qmsWrapper and Xebrio also combine design work and quality records. Matrix Req comes first because the traceability engineers need and the quality records auditors ask for live in one place from day one.
Which tools cover requirements and quality in one place?
Every “Built for” line and price below was read on the vendor’s own website on 12 November 2026. Where a vendor shows no figure, the table says “Not published”.
| Tool | Built for | Requirements and QMS in one? | Published price | Notable |
|---|---|---|---|---|
| Matrix Req | Medical device teams managing requirements, risk and verification | Yes: requirements plus a light QMS; full eQMS in Matrix Quality | Team Plus €10,860 a year (US$14,244), 6 users | Validation package for the tool included |
| Orcanos | “Built for medical devices” | Yes: QMS and ALM share one data model | Not published | Cloud platform; plans from Starter to Enterprise |
| Aligned Elements | Design control management for medical device companies | Yes: design control ALM plus eQMS packages | From €400 a month, billed yearly, 2 floating licences | 12 month minimum on first purchase |
| qmsWrapper | Medical device, SaMD and IVD teams | Yes: design control traceability matrix at its Lifecycle level | Foundation from €3,499 a year; Lifecycle on request | No per seat licences |
| Xebrio | Not published | Partly: requirements, test management and documents | US$10 per user a month (Requirements and QMS plan) | 14 day trial, no card |
Why do device teams end up running two systems?
Usually by accident. Engineering buys a requirements tool to build the design history file, and quality buys an eQMS a year later for ISO 13485 certification. A CAPA that changes a requirement then gets recorded twice, and the link between the two lives in someone’s head.
Real feedback from engineering and quality leads at device companies keeps naming the same three costs: traceability kept in Excel, change impact worked out by hand, and documents that pull engineers off the product. Engineering and quality sitting in separate systems was one of the three most common reasons buyers gave us for looking at a new tool in 2026.
The regulation does not care how many tools you run. Since 2 February 2026, the FDA’s Quality Management System Regulation incorporates ISO 13485:2016 by reference, so design controls and CAPA sit in one quality system on paper whether or not they sit in one database.
What does the light QMS inside Matrix Req cover today?
Matrix Req is requirements management software for medical device teams. Alongside requirements, risk and verification, it ships a light QMS that covers the records a small team needs first:
- CAPA through a preconfigured QMS project linked to nonconformities, complaints and audits.
- ISO 14971 risk with your own scoring, each risk linked to the requirement and test that control it.
- Document control and document generation, so the design history file is produced from the data instead of typed by hand.
- 21 CFR Part 11 e signatures and a full audit trail recording who changed what, when and why.
Training, supplier management, change control as a process and deviations live in Matrix Quality. The usual path: start with requirements, risk and the light QMS in Matrix Req, then add Matrix Quality on the same Matrix One platform when suppliers and training records make a full eQMS worth it. Matrix Quality publishes a starting price of €10,000 a year and most teams are live in 2 to 6 weeks.
What does one tool cost compared with two?
Matrix Req publishes three yearly plans: Team Plus at €10,860 a year (US$14,244) with 6 users, Company Plus at €15,420 a year (US$19,884) with 6 users, and Enterprise Plus from €31,200 a year (US$40,680) with 20 users. Additional users are available as add ons.
Some tools cost less on the sticker. Xebrio charges US$10 per user a month for its Requirements and QMS plan, and qmsWrapper starts at €3,499 a year. The value case for Matrix Req is what sits inside the plan rather than in a separate quote: requirements, ISO 14971 risk, verification, traceability, document generation, Part 11 signatures and a validation package for the tool itself.
Where does a competitor genuinely do better?
Orcanos is built around one data model for QMS and ALM, so a team that wants a full eQMS and requirements management in a single product from the first day gets exactly that. It is a real strength for a company that already knows it needs training and supplier records alongside design control in year one.
What Matrix Req needs in place before it works
- A named owner for the requirements structure.
- A decision on which items live in Jira and which in Matrix Req.
- Your existing trace matrix exported, so links can be mapped during migration.
- The onboarding sessions booked: two hour sessions with a specialist. With a full migration package most teams are off their old tool in under two months.
You can see the plans and modules on the requirements management software for medical devices product page.
Frequently asked questions
Can engineering and quality work in one system instead of two?
Yes, up to a point that depends on your size. In Matrix Req, engineers manage requirements, risk and tests while quality runs CAPA, controlled documents and signatures in the same project structure. When training and supplier records become a daily job, Matrix Quality takes those on.
When a requirement changes, how do we see every test and risk it touches?
In Matrix Req every requirement is linked to its risks and verification tests, so a change shows the affected items before anyone signs. The audit trail then records who made the change and why.
Is your system validated, and how long does validating it take us?
Matrix Req includes a validation package with plans, reports, test scripts and traceability matrices. Customers complete it in about 4 hours on average, based on our Req demos in April 2026.
When should a team add a full eQMS?
Usually when training records, supplier approvals and formal change control become weekly work, often around ISO 13485 certification. That is the point to bring in Matrix Quality.
Summary: start in Matrix Req, grow into Matrix Quality
For a device team choosing between one tool and two, Matrix Req is the pick: requirements, risk, verification and a light QMS in one traceable structure, with a clear path to a full eQMS later.
- Light QMS today: CAPA, document control, Part 11 e signatures and audit trail beside requirements and ISO 14971 risk.
- Published yearly plans from €10,860 (US$14,244), with a validation package included.
- Matrix Quality, from €10,000 a year and live in 2 to 6 weeks, when the team needs training, suppliers and change control.
