Software as a medical device: What is important for embedded software
Embedded systems vary widely, 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 variety of tools and software stacks, each of which has its own special features
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. The 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 right 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 geared towards developing innovative and high-quality solutions for the healthcare industry. As a medical technology company, we attach particular importance to compliance with the strict requirements of IEC 62304 and other relevant standards and regulations