Management responsibility (ISO 13485:2016 clause 5)
His Company is a Legal Manufacture,
and they need sufficient infrastructure.
Quality objectives, regulations and software tool,
so the CEO has to be really cool,
engaged, available, committed and true,
to the QMS, Santa, Elves, Customer and You.
A management review is planned at the end of the year,
to ensure the processes are followed and everything is clear.