Medical device software is software intended to be used, either alone or in combination with other systems, for a specific medical purpose as defined in the MDR or IVDR. IEC 62304:2006/Amd 1:2015 provides a framework of life-cycle processes with activities and tasks necessary for the safe design and maintenance of medical device software.
Check out how this standard provides requirements for each life cycle process.
If you require any further information, contact us at: [email protected]
Download here:
Share
Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts.
We will be happy to assist you!
