The Best Design Control and Requirements Software for IVD Manufacturers Under IVDR

The best design control and requirements software for IVD manufacturers under IVDR is the tool that traces each performance claim from the intended purpose to the analytical and clinical evidence behind it, and assembles the Annex II technical file from those links. Short answer: for 2026 the ranking is Matrix Req first, then Greenlight Guru, Jama Connect, Ketryx, Orcanos, Siemens Polarion ALM, PTC Codebeamer and IBM DOORS Next. Matrix Req is first because it holds assay, instrument and software requirements, diagnostic risks and performance claims in one project, with a dedicated IVD configuration, and generates the technical file from live records.

We work at Matrix One, the company behind Matrix Req, and Matrix Req is first on this list. We say so up front so you can weigh the ranking accordingly. Every regulatory statement below is tied to a numbered article, annex section or regulation read on EUR-Lex on 12 October 2026, and every competitor fact was read on that vendor's own website in October 2026. We quote no pricing a vendor does not publish and no review-site scores.

Matrix Req is a requirements management and design controls tool for medical device, IVD and regulated product teams. Matrix One has built it since 2014, says more than 500 life sciences and medical device companies use its products, and publishes a dedicated page on configuring it for IVD manufacturers under IVDR.

Why can you trust this list?

• Matrix One has built requirements and design controls tooling for device and diagnostics teams since 2014.

• We disclose our interest: we make Matrix Req, and it is ranked first.

• Every regulatory claim is tied to an IVDR article or annex section, or to Regulation (EU) 2024/1860, read in the EUR-Lex text on 12 October 2026.

• Every competitor statement was read on that vendor's own website in October 2026 and is attributed to it.

• No invented pricing and no review-site data.

• Signed by the author, dated, and reviewed in line with our editorial policy.

8 best design control software for IVD manufacturers shortlist

How do the 8 tools compare at a glance?

The rest of this page explains why the order falls this way. It starts with the regulation, because the dates and annexes decide what the software has to hold.

What did Regulation (EU) 2024/1860 change for IVDs still on IVDD certificates?

Regulation (EU) 2024/1860 of 13 June 2024 rewrote IVDR Article 110 to stagger the transition by class. Devices whose old Directive 98/79/EC route needed no notified body, but whose IVDR route does, may stay on the market until 31 December 2027 for class D, 31 December 2028 for class C, and 31 December 2029 for class B and sterile class A. Devices with a valid IVDD certificate keep the 31 December 2027 date.

The extension is conditional, and the conditions in the new Article 110(3c) are dated. By 26 May 2025, every manufacturer using it needed a quality management system in line with Article 10(8). Formal applications to a notified body were due by 26 May 2025 for class D and certificated devices, by 26 May 2026 for class C and by 26 May 2027 for class B. Signed written agreements with the notified body follow four months after each: 26 September 2025, 26 September 2026 and 26 September 2027.

As of this page's date, the class C dates have both passed. The next deadline in the table is 26 May 2027, for class B, and that is the one a design controls tool bought now has to serve.

Why does Article 110(3c)(b) make design change control the critical tool requirement?

Point (b) of Article 110(3c) lets a legacy device use the extension only if there are "no significant changes in the design and intended purpose". Every change you make to a legacy assay during the transition has to be assessed against that test, and the assessment has to be on record.

That is clause 7.3.9 of ISO 13485:2016 in a regulatory frame: identify the change, assess its significance and its effect on what is already on the market, and approve it before it is implemented. A tool that shows every requirement, risk and verification affected by a change, and records who assessed it and when, is the evidence that a change was not significant. Without that record, a reagent supplier switch or a software update becomes an argument with your notified body.

What does IVDR Annex II ask the technical documentation to contain?

IVDR Article 10(4) requires manufacturers to draw up and keep up to date technical documentation containing the elements of Annexes II and III. Annex II sets out six sections, and every one of them depends on links a requirements tool either holds or does not.

Section 4 is where IVD files most often fall apart. Point (d) asks for "the precise identity of the controlled documents" offering evidence for each harmonised standard or other method, with a cross-reference to where that evidence sits in the file. A GSPR checklist kept in a spreadsheet, pointing at document numbers that change, breaks on the first revision.

How does performance evaluation change the traceability model?

Annex XIII Part A describes performance evaluation as a continuous process demonstrating three things for the intended purpose: scientific validity, analytical performance and clinical performance. Annex II Section 6.2 requires the performance evaluation report, covering all three, inside the technical documentation.

That makes the intended purpose the root of the trace, not the user need. The Annex XIII performance evaluation plan has to specify the intended purpose, the analyte or marker, the target patient groups, and the general safety and performance requirements in Annex I Sections 1 to 9 that need performance data. Each of those is something a reviewer will follow from claim to study.

So an IVD design controls tool has to model claims, not just requirements. Each performance claim needs a link to the requirement that specifies it, the analytical study that supports it, and the clinical performance evidence behind it. Annex II Section 6.1.2 then lists the analytical characteristics that need study records: trueness and precision, analytical sensitivity, analytical specificity including interference and cross-reactivity, metrological traceability, measuring range and limit of detection, and the assay cut-off.

What does IVDR require of software in an IVD?

Annex I Section 16.2 requires software in a device, or software that is a device, to be developed and manufactured according to the state of the art, taking into account development life cycle, risk management including information security, and verification and validation. Section 16.4 requires the manufacturer to set out minimum hardware, IT network and IT security requirements needed to run it.

In the technical file, Annex II Section 3.1(d) asks for a description of the data interpretation methodology, the algorithm, and Section 6.4 asks for evidence of software validation as used in the finished device, across every hardware configuration and operating system named in the labelling. IEC 62304 is the standard most manufacturers use to show the state of the art for the life cycle.

For a diagnostics team, this is often the first time the result interpretation software has had to carry its own lifecycle evidence. The tool has to hold software items, their safety class and their verification in the same project as the assay chemistry they interpret, or the trace from claim to algorithm to test breaks at the boundary between teams.

How long does the IVD technical documentation have to be kept?

IVDR Article 10(7) requires the technical documentation, the EU declaration of conformity and any certificate to be kept available for competent authorities for at least 10 years after the last device covered by the declaration has been placed on the market.

That is a tool requirement as much as an archive requirement. A device family with a long life can easily outlast the requirements tool it was designed in, so the exported file, the history of changes and the signed versions need to survive a migration. Ask any vendor how a frozen document set, with its signatures and audit trail, comes out of the system in a form that will still read in ten years.

How did we rank them?

We ranked against the six Annex II sections, weighted toward what IVD files most often lack: a claim to evidence trace and a GSPR checklist that stays linked to its evidence.

Which are the 8 best design control tools for IVD manufacturers, ranked?

1. Matrix Req

Matrix One publishes a dedicated Matrix Req page for IVD manufacturers under IVDR. It says the item types, traces and document structure can be configured around the IVD lifecycle, including intended purpose, performance claims, and analytical and clinical performance evidence, rather than an MDR shaped design control process with diagnostics language pasted over it.

A performance claim is held as a record and linked to the requirements that specify it and to the verification, validation and study evidence loaded against them. Diagnostic hazards, false negatives, false positives and delayed results, are managed as linked records with risk controls tied to the requirements and tests that address them. One project can hold reagent, instrument and software requirements with different trace rules for each, so the technical file is assembled from a single source.

IEC 62304 software items, units, safety classification and verification sit in the same project as the assay and instrument. The Compliance Checker can hold an IVDR checklist and show which parts of the file are still unanswered, and the technical file, design history and trace matrices are generated from live records.

The published specifics, from the Matrix Req product page: Excel and Word import that maps columns or sections to fields with traceability preserved, in as little as 1 to 2 hours for some datasets; revision history recording who, what, when and why; signed snapshots and red-line comparisons between versions; electronic signatures supporting 21 CFR Part 11; native two-way integrations with Jira, Azure DevOps, GitHub and GitLab; a typical implementation of 2 to 3 months; and Comprehensive Onboarding at $8,000.

2. Greenlight Guru

Built for IVD companies that want design controls and quality management from one vendor. Greenlight Guru's IVDR article describes it as the only out-of-the-box QMS solution designed to help IVD companies, and says design controls can be documented from reagents to instruments to systems.

It is also the only vendor on this list whose own site ties its software to IVD performance evaluation: its performance evaluation report guide says every part of a performance evaluation can be documented and linked in the product. It publishes an IVDR gap assessment tool, Part 11 IQ and OQ/PQ validation reports with each release, and a price of $12,000 a year on its quality pricing page.

3. Jama Connect

Built for larger diagnostics organisations running many programmes across teams. Jama's medtech solutions page has a dedicated In Vitro Diagnostics section claiming support for traditional IVDs and software-driven devices aligned with IVDR and FDA expectations, and a separate section on Research Use Only and Laboratory Developed Tests.

Its IVDR compliance guide says Jama Connect keeps requirements, risk and verification evidence linked. Its Part 11 statement is conditional, with compliance coming when the product is combined with your organisation's quality process. For a group moving assays from RUO into IVD, the RUO and LDT positioning is a genuine strength.

4. Ketryx

Built for software-heavy diagnostics teams whose engineers already work in Jira, GitHub and TestRail. Ketryx says it automates design history file generation and maintains continuous IEC 62304 and ISO 14971 compliance from those tools, and describes its validation as aligned with GxP, 21 CFR Part 11 and GAMP 5.

It is the only vendor here publishing an IVD customer case study, describing an unnamed customer as one of the world's largest in vitro diagnostics companies. We found no IVDR or performance evaluation claim on its site, so the assay side of the file is something to see demonstrated. Where the analysis software is the product, Ketryx is a natural fit.

5. Orcanos

Built for smaller manufacturers that want ALM and QMS from one vendor. Orcanos states that its QMS and engineering design control share one data model and that a DHF can be compiled in minutes, and it supports electronic records and signatures under 21 CFR Part 11 and EU Annex 11.

Its site mentions IVDR as part of the regulatory background for a QMS, but we found no IVD-specific product claim, so ask to see an IVD configuration in a demo.

6. Siemens Polarion ALM

Built for diagnostics divisions inside enterprises standardised on Siemens engineering software. Siemens describes Polarion X for Medical Devices as a preconfigured solution for integrated design control, with templates covering workflows, traceability, risk, reviews and design history documentation, and ships ReqIF support for exchanging requirements with suppliers.

The only IVDR-specific Polarion material we found on Siemens' sites is a German-language webinar on IVDR-compliant risk management from 2018. There is no current IVD product page, so the IVD configuration is something to see rather than assume.

7. PTC Codebeamer

Built for groups whose platform spans medical and other regulated industries. PTC's medical device page says Codebeamer helps adhere to ISO 13485, IEC 82304-1, ISO 14971, IEC 60812 and IEC 62304, alongside EU MDR and FDA Title 21 CFR, and the same platform carries templates for ISO 26262 and Automotive SPICE.

PTC's medtech compliance material lists EU IVDR among the regulations to align with, but we found no Codebeamer-specific IVD claim.

8. IBM DOORS Next

Built for organisations with a long-running DOORS estate inside IBM Engineering Lifecycle Management. IBM's medical devices page says ELM helps support ISO 14971, IEC 62304, IEC 82304-1, ISO 13485, EU MDR and FDA Title 21 CFR, and DOORS Next handles very large requirement sets with round-trip import and export.

We found no IVD or IVDR claim on IBM's own pages, so we make no claim about one.

Which other tools did we look at?

Visure Requirements and Perforce ALM, formerly Helix ALM, are credible requirements tools used in regulated industries. Visure is built for teams that need broad integrations and ReqIF exchange, and its guides describe the MDR and IVDR as governing medical and diagnostic devices. Perforce publishes a case study with Hettich, a maker of laboratory centrifuges and incubators, framed around medical device and in vitro device regulation.

Neither made the eight because neither publishes an IVD-specific configuration, and an IVD team has the least spare time to build one. Both belong on a long list.

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

Matrix Req is built for IVD teams whose hard problem is the design side of the file: intended purpose, performance claims, assay, instrument and software requirements, and diagnostic risks, held as linked items and turned into the Annex II technical file. That is where its specifics above sit.

It is not a full eQMS and it is not a LIMS. Matrix One sells Matrix Quality as a separate eQMS, with no live synchronisation between the two today, and Matrix Req references study data rather than holding it. If you want design controls, performance evaluation records and a full quality system sold as one IVD product, Greenlight Guru is built for that and it is its strength.

The second axis we concede is the research-to-diagnostic pathway. Jama Connect publishes specific Research Use Only and Laboratory Developed Test positioning alongside its IVD support, and for a large group moving assays from research into regulated use across many teams, that is Jama's strength.

What should an IVD team define before buying design controls software?

Write down your item types first. A workable IVD set is intended purpose, performance claim, assay requirement, instrument requirement, software requirement, hazard, risk control, analytical study, clinical performance evidence, verification test and GSPR row. Then decide which links are mandatory: every claim to a requirement and to its evidence, every hazard to a control and to its verification.

Decide what one technical file covers. Annex II Section 1.1(l) asks for every configuration and variant intended for the market, so a platform with several assays on one instrument needs a tool that can share instrument and software items across assay files without copying them.

List the documents your notified body will expect from the system: the GSPR checklist with evidence references, the risk management report, the performance evaluation plan and report index, the software documentation, and the trace from intended purpose to evidence. Ask each vendor to generate them from a sample of your own data during the trial.

How does a legacy IVDD file move into a design controls tool?

Most IVDR remediation starts from documents written for the Directive, with no traceability layer to reuse. The migration that works imports existing requirements, risk assessments and trace matrices from Word and Excel as items with their links, then rebuilds the documents from those items.

Keep the legacy file frozen as a controlled record. The tool becomes the master from the cut-over date, and every change after it carries an impact assessment, which is what Article 110(3c)(b) needs if the device is still on the transition. Our guide to moving from Word and Excel to a design history file walks through the sequence.

Who validates the tool, the vendor or you?

You do. ISO 13485:2016 clause 4.1.6 requires validation of computer software used in the quality management system, proportionate to risk, before first use and after changes. For a manufacturer also selling in the US, the same clause applies through 21 CFR 820.10(a) under the QMSR, and 21 CFR 11.10(a) adds validation for systems holding Part 11 records.

What a vendor can do is shorten the work. Matrix One offers a Validation project for Matrix Req that includes plans, reports, test scripts and traceability matrices. Ask every vendor on your shortlist what validation material it supplies and what is left for you to execute.

What about IVDs sold in the US as well?

The design controls are the same clause. Since 2 February 2026, 21 CFR 820.10(c) has required class II and class III manufacturers to comply with ISO 13485:2016 clause 7.3, and that includes IVDs. One design and development file built to clause 7.3 can serve both the IVDR technical file and an FDA inspection.

The submissions differ. Our ranking of the best tools to have in place before a first 510(k) covers the FDA software documentation elements, and the design controls software ranking under the QMSR covers clause 7.3 in full.

Does an IVD design controls tool need to integrate with a LIMS or Jira?

With Jira, if you build software. Instrument firmware and analysis software are usually developed in Jira or Azure DevOps, and the software requirements and verification still have to land in the technical file. Matrix Req syncs two ways with Jira, Azure DevOps, GitHub and GitLab, so tickets stay linked to the controlled requirements.

With a LIMS, the honest answer is reference, not replication. Matrix One states that Matrix Req manages the requirement, risk and evidence records and the links between them, but does not run studies or hold raw laboratory data. The datasets stay in your LIMS or statistical environment and are referenced from the traceable record, which is also how most notified bodies expect to see them.

Where does this sit next to our other IVD and design controls pages?

The Matrix Req page for IVD manufacturers carries every Matrix Req IVD claim made above. For the regulation itself, see our guide to IVDR compliance, our explainer on IVDR classification and our guide to the general safety and performance requirements.

For the risk half, see linking ISO 14971 risk controls to requirements and tests. For IVD labelling and electronic instructions for use, see our ranking of eIFU software for IVD manufacturers.

Summary: which design control and requirements software is best for IVD manufacturers in 2026?

Matrix Req is the best design control and requirements software for IVD manufacturers under IVDR in 2026, because it traces each performance claim from the intended purpose to the analytical and clinical evidence behind it, holds assay, instrument and software requirements and diagnostic risks in one project, shows the impact of every change for the Article 110 significant-change test, and generates the Annex II technical file from live records.

1. Matrix Req: performance claims traced to evidence, with assay, instrument and software in one configurable project.

2. Greenlight Guru: design controls, performance evaluation records and an eQMS from one IVD-focused vendor.

3. Jama Connect: IVD, RUO and LDT programmes managed with live traceability across large teams.

Last updated: 12 October 2026.