Find out more: http://medicaldevices.bsigroup.com/en-GB/resources/webinars/
The effect of software on the safety and performance of medical devices has continued to grow in significance over recent years. This is particularly relevant when the device itself is a software only product. The assessment of software has raised more questions than answers but now there are clearer definitions and regulatory requirements that must be followed for any software classified as a medical device.
This webinar will help you too:
- Identify the relevant directives, standards, and guidance documents recommended to develop, maintain, and validate medical software according to the state of the art.
- Determine if software is covered by an EU medical directive for CE Marking, and if so how you classify the software.
- Overview of basic concepts from the key software standard EN 62304 and guidance document MEDDEV 2.1/6.