Development of Embedded Software for Medical Devices

Safe, compliant and ready for the future
We develop embedded software for your medical device – certified according to ISO 13485 and ISO 27001. Our expertise ranges from firmware for sensors and actuators to complex embedded system architectures.
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Our Services
for Embedded Systems

FIRMWARE DEVELOPMENT IN C++

Development of efficient firmware in C/C++ for micro controllers and embedded systems. Optimized for deterministic behavior, minimal latency, and resource-efficient operation – with or without RTOS.

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LINUX-BASED EMBEDDED SYSTEMS

Development of software modules on Linux systems. Ideal for complex, high-performance medical devices with advanced features.

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SENSOR & ACTUATOR CONNECTION

Integration of sensors and actuators via CAN, SPI, I²C, BLE, or UART. Secure signal processing and precise control for reliable measurement and control processes.

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MDR APPROVAL & QUALITY MANAGEMENT

Development in accordance with ISO 13485, IEC 62304, and IEC 60601-1. Complete regulatory documentation and support for MDR or FDA approval.

Our Process

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System Concept & Device Interaction

We develop the system and software architecture for your embedded solution, define interfaces and communication protocols, and optimally coordinate hardware and software. In doing so, we take into account operating concepts, usability, and cybersecurity to ensure that your device is secure and intuitive to use.

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Implementation & Documentation

We program your embedded software in accordance with IEC 62304 and using established standards such as MISRA-C. We ensure that the code is robust and future-proof through clean architecture and consistent documentation.
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Testing & Verification

We ensure the quality of your software through unit tests, integration tests, and hardware-in-the-loop testing. Every requirement remains fully traceable, and verification is carried out in accordance with the applicable regulatory requirements – reliably and auditably.
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Maintenance & Operation

After launch, we provide long-term support. We take care of updates, maintenance, and support – from over-the-air updates to vulnerability management – and ensure that your software remains stable, secure, and compliant at all times.

FAQ

Does QuickBird Medical also develop the hardware?

QuickBird Medical specializes in the development of embedded software for medical devices. Hardware design and production are handled by a specialized partner.

How does the collaboration with my internal hardware team work?

We work closely with your internal hardware team. The process begins with the specification and interface definition and continues through to testing on the end device. We ensure clear coordination and iterative feedback loops so that software and hardware are developed hand in hand. On request, we can also assist you with the documentation required for regulatory approvals of medical devices.

Can QuickBird Medical also adopt and expand existing firmware?

Yes, we can build on existing firmware, expand it, or modernize it. To do this, we analyze the existing code, check compatibility and architecture, and then develop new components or optimize existing functions in a targeted manner. In doing so, we ensure that your software is developed in compliance with MDR and standards.

What really sets us apart

3 - ISO 13485

ISO 13485 certified

Our quality management system is certified according to ISO 13485. This ensures that we develop software as a medical device in compliance with regulations and meet the requirements of the MDR and FDA (21 CFR) for quality management systems.

ISO 27001

ISO 27001 certified

QuickBird Medical is ISO 27001 certified for information security. We are experts in the areas of cybersecurity and health data protection.
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External placing on the market

If required, we assume legal responsibility for standalone software medical devices to ensure compliance with all regulatory requirements of the MDR. This allows you to focus on your core competencies such as sales & marketing or hardware design.
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Case Study

Combyn BioCore Loop 

QuickBird Medical developed the software for the Combyn BioCore Loop autonomous health terminal in four key areas: the embedded system for signal processing, the display interface for the hardware, the server backend, and the associated web interface. It is the interaction of these components that enables the independent measurement and combination of ECG data and bioelectrical impedance analysis for a holistic cardiovascular assessment in pharmacies, gyms or offices.

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About QuickBird Medical

QuickBird Medical Managing Directors Malte Bucksch and Stefan Kofler

In the heart of Munich, our team of 30 develops software solutions for pharmaceutical and medtech companies, clinics, and digital health startups – customized, regulatory compliant, and certified according to ISO 13485 and ISO 27001. Thanks to our 10 years of experience in developing medical device software, we meet the regulatory requirements that apply to the development of Embedded Software for Medical Devices. We help you to implement these safely and efficiently in the overall product.

Are you planning a new medical device with
embedded software?

Contact us for a free initial consultation. We will be happy to advise you on the technical implementation, cost estimate, and regulatory requirements of your project, with no obligation.
Contact us