Adding to the discussion, from my academic experience, for the documentation for any test done for a medical device,in general the risk management file which is done by QA department. For example, a medical electrical device evaluated according to standard IEC60601-1.
– Instructions for use, labeling and marking , including information essential for using the correct
test parameters, such as frequency of the power supply, electrical operating voltages, degree of protection against moisture, etc.
– Definition drawings, technical data
– List of critical electrical components (always requested when evaluating a medical electrical device)
And regarding the packaging for a medical device, the FDA has several regulations mentioned on “medical device packaging design – Sec. 820.130 Device packaging under Subpart K–Labeling and Packaging Control.
https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm095308.pdf