Medical devices
ISO 13485
Medical Device Quality
ISO 13485 implementation consultants for medical device manufacturers and contract manufacturers. WCH harmonizes ISO 13485 with FDA QSR / cGMP into one QMS — design controls, risk, validation, CAPA — ready for the registrar and the FDA.
Who it is for
Device manufacturers, contract manufacturers, component suppliers, and combination-product organizations that must satisfy ISO 13485, 21 CFR 820, and customer quality agreements.
What is at stake
A finding here is not a paperwork problem. It is a warning letter, a delayed 510(k), or a lost contract manufacturer relationship. The system has to be inspection-ready every day, not just audit week.
The WCH approach
WCH harmonizes ISO 13485 and GMP into one QMS — one manual, one set of SOPs, one internal audit program. Design controls, risk (ISO 14971 alignment), process validation, CAPA, and supplier controls that stand up to notified bodies and the FDA.
- ISO 13485 certification and a QMS aligned to 21 CFR 820
- Harmonized ISO and GMP manuals — not two competing systems
- Internal audit and FDA inspection readiness
- Documented zero-NC ISO and FDA audit performance for clients who put the system to work
ISO 13485 implementation, internal audit, and training
Organizations hire WCH for the work that leads to certification — not a binder and a wave goodbye.
- ISO 13485 and QSR gap analysis
- Harmonized quality manual, SOPs, work instructions, and forms
- Internal audit program and auditor training
- CAPA, complaint, and management review structure
- Registration and inspection support
Nationwide ISO 13485
ISO 13485 consultants serving every U.S. state
Open your state for a page written for local industry, then request a quote online from ISO 13485 specialists.
ISO 13485 questions
WCH Professional Services
Choose WCH. Choose Success.
Request a quote online or call (570) 350‑9256. Tell us the sites and the date you need to be ready.