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. What comes after approval is planned in from the start: updates, discontinued components and support for the series.
Triggers
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 are to run over the network. That turns the software architecture into a safety question: who may do what, and how a signed update reaches the device.
An idea from practice, no device yet. We check feasibility, build a functional model and stay with the device through development, 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 life cycle per safety class. Requirements, tests and releases live in the requirements and test management system you have access to from day one.
Usability. We derive operating concepts from your risk analysis, design the interface accordingly and support your usability studies.
Risk management. Whatever the risk analysis demands in software and hardware measures, we implement and trace back to the test.
We comply with electrical safety and with EMC under 60601-1-2. Measurements run alongside development in-house and, for approval, at the test laboratory.
Our management system conforms to 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 transfer into production.
MedTech
The FREI GUIDE training control redesigned from the ground up: from the Linux drivers through the software architecture to the user interface, with approval documentation to IEC 62304.
Series
We keep an eye on 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 what the change touches in the documentation.
Every change is assessed against intended purpose and risk analysis. We deliver the assessment and the updated evidence; whether a notification to the notified body is due, you decide with your regulatory affairs.
Updates and remote access run through qdCloud, hosted in Europe or on your own infrastructure.
Matching building blocks
Gateway, single-board computer and modules as a product base. Your team builds the application; the board project is gone.
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Buildroot-based Linux with a mainline LTS kernel. Brings the device side for updates, logging and certificates with it.
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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 assembly 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 series release.
Firmware, embedded Linux and the application on top, for devices with a long field life.
Image processing and pattern recognition on the device, with a provable model version over the field lifetime.
Unit tests through EMC measurement, with reports you can present in an audit.
Safety concept, safety requirements and the path to the certificate.
Secure boot, signed updates and vulnerability management across the field life.
Frequent questions
No. The manufacturer under the MDR remains you, with your person responsible for regulatory compliance. We deliver the technical documentation of the development, accompany the assessment at the notified body and answer its questions on our part.
Our management system conforms to 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 transfers to you: design, software and manufacturing data, governed by the development contract. Our own building blocks remain our product; documents for them are held by an independent party so that you can carry on if we fail.
Next step
Describe the device, its risk class and your schedule. We will tell you how we would approach the project and where we see risks for approval. The evaluation up to a budgetary price is free of charge.
