ISO 13485 is the device QMS standard used globally. In the United States, 21 CFR 820 (QSR) and cGMP still apply. Running two manuals is how records diverge and inspections go badly.
WCH harmonizes ISO and GMP into one QMS: one manual, one set of SOPs, one internal audit program. Design controls, risk, process validation, CAPA, complaints, and supplier controls are written once and evidenced once.
Client results are the point. One pharmaceutical manufacturer working with WCH reported six ISO annual audits with zero NCs, two FDA surprise audits with zero NCs, and more than fifty customer audits with zero critical NCs.
Contract manufacturers need the same discipline with a scope that matches the role they actually play in the device lifecycle. We size the system to that role so you are not documenting design controls you do not own.