Are there any wire harness manufacturers who understand process validation and test method validation for medical device customers?

[Stoic]

We're finding that the wire harness manufacturers selected by two of our contract manufacturers have zero understanding of process validation (PV) and test method validation (TMV / MSA). This includes one that has staff certified to train personnel to IPC/WHMA-A-620 and whose business is 30% comprised of medical device customers. These are custom wire harnesses, not off-the-shelf, and IPC-620 appears to contain nothing that would support an argument that FDA regs don't apply here. Documentation from at least one terminal crimp supplier (Molex, IIRC) actually recommends both PV and TMV (which it should, because crimp joints are a common failure point).

It's beginning to feel like FDA-compliant wire harness manufacturers are a rarity. What have y'all experienced when outsourcing this process, and which firms are actually qualified?