Software is commonly used within medical devices, but what are the impacts of relying on software for basic safety and essential performance?
Due to the complexity of software, the medical device standard IEC 60601-1 Ed 3.1 has a normative reference to IEC 62304 forcing many medical device manufacturers to comply with IEC 62304 as part of their certification. IEC 62304 is a functional safety standard that defines the life cycle requirements for medical device software providing processes, activities and tasks to ensure safety.
Watch this on-demand webinar to:
- Understand the correlation between IEC 60601-1 Ed 3.1 and IEC 62304
- Learn more about the regulatory expectations and key processes described in IEC 62034
Gustav Hoppe, staff engineer
Over 13 Years with UL as a project handler and reviewer for medical devices including software and usability.
April 15, 2021