Development of Embedded Software for Medical Devices
MDR Medical Devices & FDA Approval: Safe and compliantWe 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.
Our Services
for Embedded Systems
FIRMWARE DEVELOPMENT IN C/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.
LINUX-BASED EMBEDDED SYSTEMS
Development of software modules on Linux systems. Ideal for complex, high-performance medical devices with advanced features.
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.
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
Requirements & Classification
From your system requirements and risk analysis we derive testable software requirements and assign every software item a safety class according to IEC 62304. This classification determines the regulatory effort across the whole project.
Architecture & System Design
We structure the architecture so that safety-critical parts are separated from non-critical ones. This segregation keeps the effort where it belongs instead of raising the entire software to the highest class.
Implementation & Reviews
Development in short cycles with code reviews, coding standards and static analysis. Third-party software is handled as SOUP (Software of Unknown Provenance), with assessment, a fixed version state and monitoring of known vulnerabilities.
Verification & Release
Unit, integration and system tests with end-to-end traceability from requirement to test case. Every result is documented, so the technical documentation is complete and ready for audit at release.
FAQ
Which MDR risk classes and IEC 62304 software safety classes does QuickBird Medical have experience with?
We have experience with all software safety classes of IEC 62304 (A, B and C) and with all MDR risk classes (I, IIa, IIb and III), including software whose failure can lead to serious injury or death. For these safety-critical parts we implement the full Class C requirements of IEC 62304: architecture down to the level of the individual software unit, detailed design, verification of every unit, control of SOUP components and complete traceability from the requirement through the code to the test case.
It is important to know that the two classifications are independent of each other. The MDR risk class applies to the device as a whole, while the IEC 62304 software safety class is assigned per software unit. A Class IIa device can therefore contain Class C software. For non-critical parts such as display, logging or connectivity, we deliberately keep the effort low through clean segregation instead of raising the entire system to the highest class.
Where are the employees of QuickBird Medical based?
All of our employees work in Munich, Germany. We do not use nearshoring or offshoring. We develop with our own in-house team. For you, that means English- and German-speaking contacts in your time zone, short distances for on-site meetings and a well-established team sharing one development lab in Munich.
How does the collaboration with my internal hardware team work?
Can QuickBird Medical also adopt and expand existing firmware?
What really sets us apart
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 certified
External placing on the market
Device classes
Embedded software for a wide range of medical devices
QuickBird Medical develops embedded software for medical devices of widely differing designs. These range from patient monitors and vital sign measurement to imaging systems such as ultrasound, laboratory analysers and point-of-care diagnostics, through to mobile handheld devices and wearables. Whether real-time signal processing, safe device control or the connection to backend and app: we develop the software in line with IEC 62304 and support you all the way through to approval.
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.
About QuickBird Medical
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.
QuickBird Medical in Numbers
35+
Medical Software Projects
… successfully implemented for our clients.
10+
Years
… since QuickBird Medical was founded
30
Medical Software Experts
… all based in Munich
15+
Countries
… in which products we developed are in use.