Medical devices
ISO 13485
Medical Device Quality
ISO 13485 plus FDA QSR and cGMP is how medical device companies stay on the market. WCH has taken organizations through ISO audits and FDA inspections with zero nonconformances.
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
What you receive
- 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, with a path to request a quote from ISO 13485 specialists.
ISO 13485 questions
WCH Professional Services
Put ISO 13485 in the hands of a firm that has never missed.
Call (570) 350‑9256 or send the sites and the date you need to be ready.