I work at an organization that manufactures Class II medical devices.
We are having debate on where the technical file resides. Engineering or Quality.
The design engineering group submits the devices for listing (60601-1 3rrd ED).
Our engineering manager thinks the technical file resides in quality assurance.
How do other organizations manage this?
Thanks
We are having debate on where the technical file resides. Engineering or Quality.
The design engineering group submits the devices for listing (60601-1 3rrd ED).
Our engineering manager thinks the technical file resides in quality assurance.
How do other organizations manage this?
Thanks
