Risk Management in Product realization
(ISO 13485:2016 clause 7.1)
Exhausted and tired they really need a break,
to celebrate the third Advent with a Christmas cake.
They document and summarize the risks in a perfect file,
and continue with the requirements with a satisfied smile
Requirements is compiled in the trace matrix
When can the CE-mark finally be affixed?
The report must be ready before Christmas week,
and shall prove the product is robust and not weak.