Description
This QMS conforms with IEC 62304, which is a medical device software life cycle process standard. However, it does not comply with the related standard IEC 82304-1:2016, which defines general requirements for product safety for health software.
Description of the issue
Although IEC 82304-1 is not yet a harmonised standard, Notified Bodies increasingly expect products to conform to it, as it is considered state of the art. Non-alignment may therefore constitute a regulatory risk.
Suggested Solution
Perform a full gap analysis against IEC 82304-1 and add the missing requirements into the QMS.
What could be done to fix this
Update QMS procedures, work instructions, and templates to cover IEC 82304-1 requirements.
Description
This QMS conforms with IEC 62304, which is a medical device software life cycle process standard. However, it does not comply with the related standard IEC 82304-1:2016, which defines general requirements for product safety for health software.
Description of the issue
Although IEC 82304-1 is not yet a harmonised standard, Notified Bodies increasingly expect products to conform to it, as it is considered state of the art. Non-alignment may therefore constitute a regulatory risk.
Suggested Solution
Perform a full gap analysis against IEC 82304-1 and add the missing requirements into the QMS.
What could be done to fix this
Update QMS procedures, work instructions, and templates to cover IEC 82304-1 requirements.