Hi Everyone!
My company develops software for medical devices and I am updating our processes and templates for compliance with IEC 62304.
Section 5.2.2 Software Requirements Content contains some requirements type that we don't typically include in our SRS (software requirements specification) but that wouldn't hurt to add. There are, however, some other types that I am not sure about. Can anyone provide examples or an explanation of "requirements related to methods of operation and maintenance" and "user maintenance requirements"?
Thanks so much!
Cathy
My company develops software for medical devices and I am updating our processes and templates for compliance with IEC 62304.
Section 5.2.2 Software Requirements Content contains some requirements type that we don't typically include in our SRS (software requirements specification) but that wouldn't hurt to add. There are, however, some other types that I am not sure about. Can anyone provide examples or an explanation of "requirements related to methods of operation and maintenance" and "user maintenance requirements"?
Thanks so much!
Cathy