Neurotech and Brain Computer Interfaces with Matrix Req
Neurotech teams are small, the devices are Class III, and the evidence burden is the same as a company ten times the size. Matrix Req gives you requirements, risk and test evidence in one place, without the weight of an enterprise ALM.
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The challenge
Class III complexity carried by a team of ten
Implanted neurostimulators, brain computer interfaces and closed loop neuromodulation sit at the top of the risk classification, and they are usually built by small teams working at startup pace. The regulatory expectation does not scale down with headcount.
- Highest risk classification.Most implanted neuro devices are Class III in the EU and follow a PMA or IDE route in the US, which means clinical evidence, a complete design history and a technical file that holds together under scrutiny.
- Four disciplines, one traceability chain.Electrode and lead hardware, implant firmware, an external programmer and often a mobile or cloud application all have to trace back to the same clinical need.
- Long implant life.Risk management has to account for years in the body, and the ISO 14708 series adds device specific requirements on top of ISO 14971.
- Requirements scattered by default.Specifications live in Word, the traceability matrix lives in Excel and the engineering work lives in Jira, so nobody can answer what a change actually affected.
- Enterprise tools priced for someone else.Teams tell us the established ALM platforms are expensive and heavy for a team this size, and end up used by one systems engineer and nobody else.
Our solution
Complete traceability, sized for the team you actually have
Matrix Req is a design control and requirements platform built for medical device teams rather than adapted from general engineering software, so a five person neurotech team can run the same rigour as a large manufacturer without hiring an administrator to keep the tool alive.
- One system for the whole chain.User needs, system requirements, hardware and software specifications, risks and test cases live together, with traces you configure once and enforce from then on.
- ISO 14971 risk that stays connected.Hazards, risk controls and the verification that proves each control works are linked records, so a design change never leaves a control orphaned.
- IEC 62304 alongside the hardware.Software items, units and their verification sit in the same project as the implant and the programmer, not in a separate tool.
- Keep working in Jira.Two way synchronisation means engineers stay in their tracker while the controlled requirement set stays controlled.
- Documentation generated, not written twice.Design history, traceability matrices and submission documents are produced from the live records at the point you need them.
Core Features
What Matrix Req does for neurotech and neurostimulation programmes.
Risk Management for Long Term Implants
Manage hazards, risk controls and residual risk to ISO 14971, with the ISO 14708 series expectations for active implantable devices reflected in your own templates and formulas.
Learn moreHardware, Firmware and Software in One Project
Trace an electrode specification, an implant firmware requirement and a programmer application feature back to the same clinical need, without three separate tools.
Design Control and Impact Analysis
See exactly what a requirement change touches downstream before you make it, including which risk controls and test cases have to be re executed.
Learn moreIEC 62304 Software Lifecycle Evidence
Document software items and units, link them to verification results, and keep the software safety classification argument visible in the same place as the evidence.
Two Way Jira and Azure DevOps Sync
Engineering carries on in the tracker it already uses while requirements, risks and test results stay under control in Matrix Req.
Learn moreSubmission Ready Documentation
Generate the design history file, traceability matrices and technical documentation from live records rather than assembling them by hand before an audit.
Learn moreHear from our customers
With Matrix Req, we avoid all the challenges of using manual or custom-developed tools. Instead, we get a purpose-built solution that’s designed by medical device experts, enabling much faster ISO 13485 compliance.”
François Audéon, Chief Technology Officer
FAQ
01Is Matrix Req suitable for a Class III neurostimulation device?
Yes. Matrix Req is used for Class III programmes including active implantable devices. It supports the design control, risk management and traceability evidence expected under EU MDR and by the FDA for a PMA or IDE submission. The classification itself is your regulatory decision, and Matrix Req holds the evidence behind it.
02Can Matrix Req handle hardware, firmware and software requirements in one project?
Yes, and this is the main reason neurotech teams move to it. A single project can hold mechanical, electrical, firmware and application software requirements with configurable trace rules between them, so the implant, the lead and the external programmer are all part of one traceability chain rather than three parallel sets of documents.
03Which standards does Matrix Req support for neurotech?
Matrix Req ships templates aligned to ISO 13485, ISO 14971, IEC 62304 and IEC 62366, and the templates are configurable, so device specific standards such as the ISO 14708 series for active implantable medical devices can be modelled as your own requirement and risk categories. The Compliance Checker lets you import a standard or build a checklist and highlights where your documentation has gaps against it.
04We run everything in Jira today. Can we keep it?
Yes. Jira is the most requested integration we see, and the synchronisation is two way, so requirements and test results stay consistent between the two systems instead of drifting apart. Teams typically keep day to day engineering work in Jira and hold the controlled requirement, risk and verification set in Matrix Req.
05How long does it take a small neurotech team to get running?
Most small teams are working in Matrix Req within a few weeks rather than the multi month rollout an enterprise ALM usually needs. Existing requirements can be imported from Excel and Word, and the medical device templates are there from day one, so you configure rather than build from nothing. For a neurotech team that wants design control and Class III traceability without an administrator to maintain the tool, Matrix Req is the right starting point.