Program Overview
ISO 13485 is the global QMS standard for medical device manufacturers. Learn to audit design controls, risk management (ISO 14971), validation, sterilisation, complaint handling, post-market surveillance and regulator alignment (FDA QSR, EU MDR).
Syllabus
Day 1 Schedule
13485 Foundations & Regulatory Landscape
Why 13485 is risk-centric (not Annex-SL aligned), and how it sits inside FDA QSR and EU MDR.
Design Controls & Design History File
Trace a representative product from design inputs through verification and validation to a defensible DHF.
Risk Management (ISO 14971) & Process Validation
Audit risk-management files, sterilisation validation, software validation and special-process controls.
Day 2 Schedule
Production, Servicing & Identification / Traceability
Audit production controls, UDI implementation, servicing records and identification.
Complaints, Vigilance & Post-Market Surveillance
Audit complaint handling, MDR/MDV reporting, CAPA, PMCF and trend analysis.
Final Knowledge Assessment
Multiple-choice assessment covering every clause area introduced in Specialty: ISO 13485 Medical Devices QMS Lead Auditor. Pass mark 70%.
This terminal assessment unlocks after you enrol. The exam grades clause-level recall; the simulation requires a passing score before drafting the closing NCR.
Closeout: Live Audit & NCR Drafting
Live War Room simulation tied to Specialty: ISO 13485 Medical Devices QMS Lead Auditor. Conduct an AI-driven interview, evidence-gather, then draft a defensible NCR.
This terminal assessment unlocks after you enrol. The exam grades clause-level recall; the simulation requires a passing score before drafting the closing NCR.
Learning Outcomes
- Audit a medical-devices QMS against ISO 13485:2016
- Trace design controls from inputs to outputs to verification & validation
- Sample risk management evidence against ISO 14971
- Audit complaint handling, vigilance and post-market surveillance
- Reconcile ISO 13485 with FDA 21 CFR 820 and EU MDR expectations