Industries · Medical technology
That is why we like developing for medical technology. Electronics, firmware and application software for medical devices and in-vitro diagnostics, with the IEC 62304 documentation delivered alongside. We plan for what comes after regulatory approval from the start: updates, discontinued components and support for series production.
Why projects start
The predecessor has been running for years, components are discontinued, assembly and service cost too much. The successor needs new electronics, the same intended purpose and documentation the notified body will accept.
Configuration, firmware updates and operating data should run over the network. That turns the software architecture into a security question: who may do what, and how a signed update reaches the device.
An idea from clinical practice, with no device yet. We check feasibility, build a functional prototype and stay with the device through development, regulatory approval and series production.
Regulation
Regulations (EU) 2017/745 and 2017/746 define what the technical documentation must contain. We deliver the development part of it: requirements, architecture, verification, contributions to risk management.
The software lifecycle for each safety class. Requirements, tests and releases are kept in the requirements and test management system, which you can access from day one.
Usability. We derive operating concepts from your risk analysis, design the interface accordingly and support your usability studies.
Risk management. We implement the software and hardware measures that follow from the risk analysis and trace them through to the test.
We meet the requirements for electrical safety and for EMC under IEC 60601-1-2. We measure in-house during development and at the test lab for regulatory approval.
Our management system is aligned with the requirements of ISO 13485. Process and development documentation have been accepted in many approvals. Should your procedures require it, we work in your QM system and with your templates.
We work to these standards and regulations.
The device goes to the patient. The responsibility lies with you and with us.
MedTech
Systems engineering, electronics and firmware for a rechargeable battery insert in several sizes, developed to IEC 60601-1 and IEC 62133-2 within the scope of the MDR, through to transfer into production.
MedTech
Systems engineering, electronics and firmware for a rechargeable battery insert in several sizes, developed to IEC 60601-1 and IEC 62133-2 within the scope of the MDR, through to the transfer to manufacturing.
MedTech
The FREI GUIDE training control redesigned: from the Linux drivers through the software architecture to the user interface, with regulatory approval documentation to IEC 62304.
Series production
We monitor the libraries and components in your device and report new vulnerabilities, so that your post-market surveillance has something to assess.
We record critical components and software parts, propose replacements and re-check which parts of the documentation the change affects.
Every change is assessed against the intended purpose and the risk analysis. We deliver the assessment and the updated evidence; you and your regulatory affairs team decide whether a notification to the notified body is due.
Updates and remote access run through qdCloud, hosted in Europe or on your own infrastructure.
Matching platform modules
Gateway, single-board computer and modules as a product base. Your team builds the application, with no separate board project.
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Buildroot-based Linux with a mainline LTS kernel. The device side for updates, logging and certificates is already built in.
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Fleet overview, updates and remote access for connected devices. Hosted in Europe or on your own infrastructure.
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Programming and testing every board at the end of the line. Results go straight into the ERP system over the network.
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Requirements, architecture and system boundaries before the first board exists.
Circuit, layout and EMC-compliant design through to the release to series production.
Firmware, embedded Linux and the application on top, for devices with a long service life.
Image processing and pattern recognition on the device, with a traceable model version throughout the service life.
Unit tests through EMC measurement, with reports you can present in an audit.
Safety concept, safety requirements and the route to certification.
Secure boot, signed updates and vulnerability management throughout the service life.
No. You remain the manufacturer under the MDR, with your person responsible for regulatory compliance. We deliver the technical documentation for the development, support the assessment by the notified body and answer its questions on our part.
Our management system is aligned with the requirements of ISO 13485; the company is certified to ISO 9001. Process and development documentation have been accepted in many approvals. If your QM system requires it, we work in your process and with your templates.
Class I, IIa and IIb under the MDR, and in-vitro diagnostics, from new development to the relaunch of an approved device.
Not to products under the MDR or IVDR; the regulation exempts them in Article 2. Accessories and companion devices without a medical purpose, a gateway for instance, may be covered. We clarify this per component at the outset.
What we develop for you is transferred to you: design, software and manufacturing data, as set out in the development contract. Our own platform modules remain our product; their documentation is held in escrow with an independent party, so you can carry on should we ever drop out.
Tell us about the device, its risk class and your schedule. We will tell you how we would approach the project and where we see risks for regulatory approval. The assessment, up to an indicative price, is free of charge.
