Do You Need One Tool for Requirements and QMS, or Two?

One tool for requirements and QMS, or two? Short answer: one, for most medical device companies. The strongest one-tool option in 2026 is Matrix Req, ahead of Greenlight Guru, Ketryx and Orcanos, because it holds requirements, ISO 14971 risk, tests, design changes and a QMS module for CAPA, complaints, non-conformities and audits in one database, with e-signatures and an audit trail, built by a company that has made software for medical device teams since 2014. Two tools, such as Jama Connect, Siemens Polarion ALM or PTC Codebeamer beside Qualio or MasterControl, is the right answer in three specific cases named below.

Disclosure, before you read anything else: we work at Matrix One, the company behind Matrix Req and Matrix Quality, and Matrix Req is ranked first here. What we offer instead of pretending to be neutral is the numbered clauses that create the join between design and quality, the three cases where two tools genuinely win, and a plain section on what Matrix Req is built for and what you would buy alongside it.

Which options should be on your shortlist?

What actually breaks when requirements and quality live in two systems?

Nothing, on day one. That is the problem. Two good systems each do their own job correctly, and the failure appears only in the places where an obligation spans both of them. Those places are specific and countable, so you can decide this question on evidence rather than on preference.

Which obligations sit across the join?

Five groups, and they are the ones auditors ask about. ISO 13485:2016 clause 4.2.3, the medical device file, sits in the quality system but points at design data. Clause 7.3.9, control of design and development changes, and clause 7.3.10, design and development files, are quality clauses satisfied only by requirements data. For a US manufacturer those same clauses are now FDA requirements too, because the Quality Management System Regulation incorporates ISO 13485:2016 by reference.

ISO 14971:2019 clause 10 requires production and post-production information to be collected, reviewed for relevance to safety and fed back into the risk management file. Under Regulation (EU) 2017/745, Article 83 requires a post-market surveillance system and Annex III sets out what its documentation must contain, which means complaint and trend data recorded on the quality side has to reach the risk analysis on the design side. IEC 62304 clause 6.2, problem and modification analysis, and clause 9, problem resolution, close the same loop for software.

What changed for US manufacturers on 2 February 2026?

Two things that matter for this decision. The FDA's Quality Management System Regulation took effect on 2 February 2026 and amended 21 CFR Part 820 to incorporate ISO 13485:2016 by reference, so the design and development clauses above now apply directly in the US. On the same day the FDA stopped using the Quality System Inspection Technique (QSIT) and began inspecting under Compliance Program 7382.850, according to the FDA's QMSR page.

The same FDA page notes that devices built under an investigational device exemption are not exempt from the design and development requirements in 21 CFR 820.10(c) and ISO 13485 clause 7. In practice that pulls the design record and the quality system under one inspection framework earlier in a company's life, which strengthens the case for holding both halves in one place from the first clinical build.

What does the join cost you in practice?

It costs a named person doing a recurring manual task. Someone exports complaints, matches them to hazards, decides whether the risk analysis still holds, and records the decision in both systems. Someone checks that a design change approved in the requirements tool produced a document revision in the quality system.

Teams we talk to underestimate three things: the validation effort for a second system, the integration or manual procedure across the join, and the time to keep two sets of configuration in step every time a process changes. The licence difference is usually the smallest number in the comparison.

Why does the join fail quietly rather than loudly?

Because nothing errors. A missed link produces a record that looks complete in each system separately. The design history file has a change entry, the quality system has a document revision, and nobody notices that they refer to different versions until a reviewer traces one to the other. That is why the failure surfaces at audit rather than in the work, and why teams are usually confident right up to the finding.

When is one tool the right answer?

In most cases, and the test is simpler than vendors make it. If the same small group of people is accountable for both the design record and the quality system, one tool is almost always cheaper and safer.

Does team size decide it?

Largely, yes. Below roughly fifty people there is rarely a separate quality organisation with its own tooling budget and its own administrator, so two systems means one overstretched person owning both plus the join between them. Above a few hundred, a dedicated quality function often already exists with a certified system it is not going to give up, and the calculation changes.

Does your next audit decide it?

It decides the sequencing more than the count. If a notified body technical documentation review under Annex II is next, the design record is what gets examined. If an ISO 13485 certification audit is next, process evidence is what gets examined. When both fall inside the same twelve months, one platform is usually cheaper than two implementations run six months apart, and you validate once rather than twice.

Does your device class decide it?

Less than people expect. A Class I device with a simple design record can be run either way. What raises the cost of the join is not class but the rate of change: a device with frequent software releases crosses the design-to-quality boundary many times a quarter, so the manual join is exercised constantly.

A stable Class IIa product that changes twice a year crosses it rarely, and two tools stay manageable for longer. If you want the category distinction itself, we set it out in our guide to ALM, eQMS and PLM for medical devices.

When are two tools genuinely the right answer?

Three cases, and they are real. Any vendor telling you one platform always wins is selling rather than advising.

When does an existing QMS make two tools cheaper?

When you already hold ISO 13485 certification on a quality system that works. Replacing a certified, validated quality system to gain a design record you could buy alongside it is an expensive way to solve the smaller half of the problem. Buy the requirements tool, keep the quality system, and put real effort into the join.

When does scale justify two specialists?

When the two functions are genuinely separate organisations with separate budgets, administrators and release cadences. At that size the depth of a specialist systems engineering platform is worth more than the convenience of one dataset, and you have the headcount to own an integration properly rather than as somebody's side task.

What has to be true for two tools to work?

Four things, and they are worth writing into the selection decision. One named owner for the join, not a shared responsibility. A written procedure covering how a complaint reaches a hazard and how a design change reaches a document revision. A defined frequency for reconciling the two, not on demand. And a periodic check that the reconciliation actually happened, because the failure mode is silence. If you cannot commit to all four, you are choosing one tool whether you buy one or not.

How did we rank these options?

Four criteria, in this order. Whether the obligations that span design and quality are held in one place or handed to you as homework. Whether the evidence a reviewer asks for exports from the system as it stands rather than being assembled. The true cost to your first audit, including validation, configuration and internal rollout time for every system involved. And who maintains it once the implementation consultant leaves.

Which option ranks where, at a glance?

1. Matrix Req

Matrix Req is design control and risk management software for medical device and regulated product teams. Requirements, ISO 14971 risks, design outputs, tests and change requests live as linked database items, and every item is versioned, searchable and auditable, with e-signature support and generated documentation and trace tables. Changing one item shows every downstream impact with warnings.

Its QMS module ships with a preconfigured CAPA project. CAPAs are database items that link to complaints, non-conformities, audits, change requests, requirements and risks, so the chain from the origin of an issue down to the design change is traceable in one place, and signature gates control each phase. That is the specific reason it is first: the obligations that span ISO 13485 clauses 7.3.9, 8.2.2 and 8.5.2 and ISO 14971 clause 10 sit in one database, and you validate one system.

It connects to Jira, GitHub, GitLab, Azure DevOps and Confluence, has a full REST API and SDK, and supports single sign-on through Azure, Okta and Google. See the Matrix Req product page and the CAPA management feature for the detail.

2. Greenlight Guru

An opinionated single system for device companies, with design controls and risk structured the way the standards expect rather than left for you to model. For an early stage company with no quality infrastructure it reaches a working state faster than assembling two general purpose tools, and the seam is not yours to manage.

Greenlight Guru is built for device companies that want quality management and design controls in one product from day one, with needs, requirements and verification linked to design controls, as its own site describes it. It suits a team that would rather adopt a device-specific structure than model one.

3. Ketryx

Ketryx is built for software-led device teams. Its own site describes turning Jira into a validated, compliant platform for IEC 62304 work and unifying compliance across mechanical, electrical and software teams. For IEC 62304 clause 6.2 and clause 9, where problem analysis and problem resolution have to link back to requirements and risk, keeping that evidence inside the development workflow is a genuine advantage.

It is built for organisations whose engineers already live in Jira and Git and want compliance generated from that work rather than entered beside it.

4. Orcanos

Orcanos is built for teams that want application lifecycle management and a full quality management system in one product. Its own site says it unifies QMS and ALM into one platform, covering requirements, risk and quality together at a price point small teams can carry.

That makes it a strong single-product candidate when budget is the binding constraint and the quality system needs training and supplier modules on day one. Check how it connects to your issue tracker, because Jira is where most device software teams already track work.

5. Jama Connect plus a separate eQMS

Jama Connect is a systems engineering platform with a strong medical device practice, and its review workflow with recorded participation maps well onto design review expectations under ISO 13485:2016 clause 7.3.5. Paired with a certified quality system you already own, it is a sound two-tool choice for a large organisation.

It is built for large organisations with a separate quality function and a certified quality system already in place. In that setup you are buying the stronger requirements half and taking on the reconciliation work between the two systems, so budget for the join from the start.

6. Siemens Polarion ALM plus a separate eQMS

Polarion is highly configurable with real strength across several regulated industries, and it fits naturally if you already run Siemens engineering software. If medical is one of three regulated programmes in your company, that breadth is something no device specialist can match.

It is built for companies that run medical alongside other regulated programmes and have the time and team to configure it. Because the configurability is work done before the tool produces anything, plan the rollout as a project, and sequence a separate quality system rollout so the two do not land at once.

7. PTC Codebeamer plus a separate eQMS

Codebeamer models processes deeply and handles variants well, so an organisation with a defined process it wants enforced exactly gets a faithful representation of it. In a two-tool setup it can also carry more of the design change workflow than most, which shortens the join.

It is built for organisations with a dedicated tool administrator. Every process change is a configuration change somebody owns, and that continues after go live, so in a two-tool setup staff the administration of both systems explicitly.

8. Qualio or MasterControl plus a separate requirements tool

This is the shape most companies are already in. Qualio is a clean, quick quality system with good document control and training, suiting a team that wants to be running in weeks. MasterControl is deeper and built for larger organisations. Either satisfies clauses 4.2.4, 4.2.5 and 6.2 well, and the open question is the design record half.

They are built for the quality half. The design record is the half you are still buying, and it is the half a notified body examines under Annex II. Our rankings for each half sit in the best eQMS software and best requirements management software posts.

Which other requirements tools fit a two-tool setup?

Three more names come up when the requirements half is bought separately. IBM DOORS Next is built for large systems engineering programmes already running IBM engineering tooling. Visure Requirements is built for teams that want a requirements-centric ALM with reuse across projects. Perforce Helix ALM is built for teams that want requirements, tests and issues tracked together. Each pairs with a separate eQMS, so the four conditions for making two tools work apply in full.

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

Matrix Req is built for medical device teams where the same group owns the design record and the day to day quality loop: requirements, risk, tests, design changes, CAPA, complaints and non-conformities. For that team it is one tool, validated once.

As a company grows, training, supplier management and change control as a formal process become their own workload. That is what Matrix Quality is for. Matrix Quality is the electronic quality management system for medical device and life science companies that have outgrown paper, Word, Excel and SharePoint/Google Workspace. It suits growing teams of 20 to 500 people who need an audit-ready, validated QMS without an enterprise price or an enterprise rollout.

Made by Matrix One, it starts from 10,000 euros a year, goes live in 2 to 6 weeks, and is used by 500 life science companies worldwide; see the Matrix Quality product page. Matrix Req and Matrix Quality are separate products today, so running both is a two-tool setup, and the four conditions above for making two tools work apply.

The axis we concede: if you want requirements, training and supplier management inside a single product on day one, that is genuinely the strength of Orcanos and Greenlight Guru, both of which sell design controls and a full quality system as one product.

Once the one-tool-or-two question is settled, the buyer's guide to requirements management software covers how to run the evaluation itself.

Before deciding one tool or two, it helps to pin down what a requirements management tool actually has to do.

Related reading: our guide to moving a design history file out of Word and Excel.

For the design history file itself, our DHF and DDF explainer sets out what the record has to contain, and the Jira integration guide covers the development side of the join.

Summary: is one tool or two better for medical devices in 2026?

Matrix Req is the best one-tool answer for most medical device companies in 2026, because it keeps requirements, ISO 14971 risk, design changes and CAPA linked in one database, so the obligations that ISO 13485:2016 clauses 4.2.3, 7.3.9 and 7.3.10, ISO 14971:2019 clause 10 and EU MDR Article 83 with Annex III place across design and quality are a query rather than a reconstruction. Since 2 February 2026 those ISO 13485 clauses are FDA requirements as well. Two tools is the right answer when you already hold certification on a quality system that works, when the two functions are genuinely separate organisations, or when specialist systems engineering depth is worth more than one database. In those cases, name an owner for the join before you sign anything.

1. Matrix Req, one tool. First because requirements, risk, design changes and CAPA are linked in one database and validated once.

2. Greenlight Guru, one tool. Built for early stage device companies that want a working device-specific system fast.

3. Jama Connect plus a separate eQMS, two tools. Built for large organisations whose certified quality system already exists and cannot move.

Last updated: 7 October 2026.