Christmas Rhyme 3rd Advent

Risk Management in Product realization
(ISO 13485:2016 clause 7.1)

Managing risk plays an important role
to improve the Company and be in total control.
The Elves evaluate the hazards and risks in several ways
and they have to work for seven days.

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.