I like this article on why the
FMEA is not risk management
here.
The
PFMEA can be a component of risk management that addresses the manufacturing process but there could be other things that the manufacturer does that might need to be considered. Depends upon how you draw the circle around the scope. For instance, who decides upon and sources the materials?
Also, if you're using EN ISO 13485:2012 and/or this is CE marked, you can't use PFMEA's they way they've been traditionally used. I won't elaborate unless you want me too.
What are you doing for risk management overall?