In Reply to Parent Post by Al Rosen
FYI, there is no such thing as a DHR template. Simply because, it is unique to your device and system. It's the collection of documents and records of the fabrication, assembly, processing, inspection and testing of the device.
Thanks for the reply Al.
But isn't there a standard list of things one must include...generalities?
Our company is based in Canada, and up here, in its guidance documentation, Health Canada lists the following:
proof/records that all operations, processes described in the DMR have been accomplished
dates of manufacturing
quantity released for distribution
device ID and control # used
labeling used for each production unit
acceptance records demonstrating that the device was manufactured in accordance with the DMR.
Would that list cover everything, or just about?