If you visit my PDM Solution.com site, http://www.pdmsolution.com, you'll see examples of documentation for using Enterprise PDM in an ISO/FDA environment. Have I looked at ASME Boiler and Pressure Vessel Codes (Section III)? No, not yet but I could.
For SolidWorks World 2010, I've submitted a session called Using Enterprise PDM in an ISO/FDA Environment. I'll have to wait and see if it is accepted.
In my opinion, the short answer is Yes, Enterprise PDM can meet the requirements. Any file type or document can be Checked Into the Vault, routed thru the Workflow and Revision Managed.
Devon T. Sowell