The how and the what of external software components (SOUP or OTS software) in medical devices

Currently, when developing software for medical devices, there are two sets of rules that deal with external software components: IEC 62304 and the FDA guidance from 2019 (‘Off-The-Shelf Software Use in Medical Devices’). IEC 62304 defines SOUP as follows: So it’s really part of the software – a package, a dependency, a module linked in.The […]

The pros and cons of current regulations on using external software components in medical device software (SOUP or OTS)

The regulations around external software components are mostly risk-averse and safety oriented. This negates the benefit of updating components frequently. In this article, we look into this contradiction. Currently, when developing software for medical devices, there are two sets of rules that deal with external software components: IEC 62304 and the FDA guidance from 2019 […]

Navigating the Waters of Risk Management for Medical Devices

Introduction In the realm of healthcare, patient safety is paramount, and this holds especially true for medical devices. The development, manufacturing, and distribution of medical devices require rigorous risk management practices to ensure that these products meet the highest standards of safety and efficacy. In this article, we will delve into the world of risk […]