Hi all,

IMHO you are scaring the guy more than is required...

It is important to be vigilant and educated, and real-life experience is important, but this is no rocket science...
I believe they can teach themselves anything and everything that they need - especially today, when so many good resources are available online for free. Courses and books can be great but they don't actually replace real-life experience. The only way to gain experience is to... experience!... The choice between a course and a book is many times a matter of personal preference. It has to do with the unique way each and everyone of us absorbs information. For me, courses are usually disappointing (and I attended quite many). When I want to consult or discuss something, I call a specialist or a knowledgeable colleague or a wise friend...
In the OP situation I would consider bringing in an experienced consultant to walk them through the initial certification, ISO 13485, regulation and all, and would look for someone who is not only knowledgeable, but who can, and wants to, also educate and grow other people while doing the job.
He who dares - wins.
Cheers,
Ronen.