01
Define the QMS and regulatory interfaces
Map legal manufacturers, sites, authorised representatives, importers, distributors, critical suppliers, device families, and outsourced processes. Then show how QMS controls produce and protect the evidence used in conformity assessment and post-market activity.
02
Prioritise evidence with device impact
Audit readiness depends on the effectiveness of design controls, risk management, supplier governance, validation, traceability, complaint handling, vigilance interfaces, post-market surveillance, nonconformity, and CAPA.
- Connect process records to device and patient risk
- Keep technical-documentation and QMS ownership aligned
- Control supplier changes and outsourced processes
- Test complaint, escalation, correction, and CAPA effectiveness
03
Design for US and international expansion
FDA QMSR has applied since 2 February 2026 and incorporates ISO 13485:2016 by reference with additional FDA requirements. A globally designed QMS can reduce rework, while every market's legal obligations remain separately controlled.
Frequently asked questions
Does ISO 13485 certification provide CE marking?
No. ISO 13485 certification assesses the QMS. CE marking depends on the applicable regulatory pathway, device classification, technical documentation, clinical evidence, conformity assessment, and other legal requirements.
Can one QMS support EU and FDA requirements?
Yes. ISO 13485 provides a strong common architecture, but EU and US regulatory additions, roles, records, submissions, reporting, and inspection expectations must remain visible.
Who issues ISO 13485 certification?
An independent certification body conducts the certification audit and issues the certificate. Regulatory conformity assessment and authority decisions remain separate where applicable.
Primary sources