Medical Devices
ISO 13485 and FDA QSR as one system, not two.
Device manufacturers and CMOs need a QMS that notified bodies and the FDA both accept. WCH harmonizes ISO 13485 with 21 CFR 820 and cGMP — and has client audit records with zero ISO NCs and zero FDA NCs.
How WCH works in medical devices
- Harmonized ISO and GMP quality manuals
- Design controls, risk, validation, CAPA, and supplier controls
- Inspection-ready every day, not just audit week
- Internal auditor training for device operations
WCH Professional Services
Choose the firm that has never missed a certification.
Tell us the standard, the sites, and the date you need to be ready. ISO, IATF, AS9100 / IA9100 — on-site, virtual, or both, serving every U.S. state.