Contact person
Ted Strandberg
Projektledare
Contact Ted
Medical device software - IEC 62304 and IEC 82304
This one-day course provides detailed knowledge of standards IEC 62304 and IEC 82304. They describe the processes, activities and tasks necessary for medical device software to maintain an acceptable quality throughout the life cycle of the medical device.
Purpose
The standards IEC 62304 and IEC 82304 are relevant to the development and maintenance of medical software when the software itself is a medical device or when the software is an embedded or integrated part of the final medical device.
The purpose of the course is for the participant to gain a better understanding of the framework of the standards related to software in medical devices.
Content
The course goes through the two standards IEC 62304 and IEC 82304. IEC 62304 mainly concerns products where the software is embedded in a medical device (hardware). IEC 82304 mainly concerns products where the software is a "standalone" product, in other words products that are used without any dedicated hardware.
Target group
Project managers and engineers, both involved in development and maintenance activities.
Company-specific course
Does the current course date not suit your working group? Contact us to book a customised course!
Programme
Programme
Areas covered during the course include:
IEC 62304:
- Kvalitetsledningssystem
- Riskhantering
- Klassificering av programvarusäkerhet
- Äldre programvara
- Process för utveckling av programvara
- Process för underhåll av programvara
- Process för riskhantering av programvara
- Process för hantering av programvarukonfiguration
- Process för att lösa problem med programvara för medicinteknisk utrustning
IEC 82304:
- Beskriva produktkrav för programvara för hälso- och sjukvård
- Processer för livscykeln för programvara för hälso- och sjukvård
- Produktvalidering av programvara
- Produktidentifiering av programvara
- Åtgärder efter införandet av programvaruprodukten på marknaden
