Software as a Medical Device: What Matters in Embedded Software
Embedded systems vary widely, ranging from small systems with tiny microcontrollers and specialized runtime environments to large systems with full system-on-a-chip technologies and Embedded Linux. This diversity requires a wide range of tools and software stacks, each with its own specific characteristics
What does embedded software consist of?
Embedded systems often consist not just of one microprocessor, but of a series of processors with different tasks:
These processors must be coordinated and communicate with each other, for example by using SPI or I²C to exchange commands and data.
Safety Classes in IEC 62304
IEC 62304 defines safety classes for medical software to ensure the safety and conformity of medical devices. Classification is based on factors such as the potential risk to patients and operators. A thorough risk assessment is the starting point for assigning the appropriate safety class. Safety classes range from A (low risk) to C (high risk). Choosing the correct class influences the entire development process, from documentation to validation. It is crucial to understand and meet the requirements for each class to ensure safety and compliance.
Our Approach and Services in the Field of Medical Software
Our approach and services in the field of “Medical Software” are focused on developing innovative, high-quality solutions for the healthcare industry. As a medical technology company, we place particular emphasis on compliance with the strict requirements of IEC 62304 and other relevant standards and regulations.
From the Field: Projects That Make a Difference
How we help pharmaceutical, medtech, and healthcare companies safely bring digital medical devices to market.
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