In the realm of medical device software development, understanding the nuances and compliance requirements of SOUP (Software of Unknown Provenance or Pedigree) is crucial.
SOUP plays a pivotal role in the development lifecycle but also brings with it a set of challenges that must be carefully managed.
This blog delves into what constitutes SOUP, its applications in medical devices, and the essential standards like IEC 62304 that govern its use.
During the design phase, medical product designers can develop the software from scratch and master everything and/or rely on existing software bricks.
With the increase in the complexity of medical products, the addition of increasingly advanced human-machine interfaces and increasingly advanced connectivity needs, we are seeing more and more the need to integrate already available software.
Most of the software available has not been developed following medical processes and is not medically certified, but it can still be integrated into medical products by following clear rules. This software, which was not originally developed for integration into a medical environment, is considered SOUP.
The choice to integrate a SOUP into a medical product must be carefully considered and requires dedicated management.
Our recommendations for choosing the integration of a SOUP are as follows:
The IEC 62304 standard outlines life cycle requirements for medical device software, providing a framework to manage SOUP.
Compliance involves:
These prerequisites require advanced skills whether in the design, execution or maintenance of the software integrating SOUPs:
Witekio brings comprehensive expertise in medical software development, ensuring compliance with IEC 62304 and addressing future challenges like cybersecurity and internal product updates.
Why Witekio?
Witekio supports you whether your medical software integrates SOUPs or not, ensuring robust and compliant development tailored to your needs.
