Course Overview

A four-day course for professionals tasked with building a QMS that meets ISO 13485:2016 plus EU MDR, US FDA QSR, and other global MedTech regulations. Covers design controls, CAPA, validation, traceability, post-market surveillance, and certification readiness – built around real MedTech case studies.

Who Should Attend

• MedTech RA/QA managers
• Project leads driving ISO 13485 certification
• MedTech startups preparing for first certification
• Consultants serving the MedTech industry

What You Will Learn

• Conduct a gap analysis against ISO 13485:2016 and EU MDR / FDA QSR
• Build a MedTech QMS documentation set
• Implement design controls, risk management (ISO 14971), and CAPA
• Establish validation, traceability, and post-market surveillance processes
• Plan complaints handling and adverse event reporting
• Prepare for certification audit and regulatory inspection

Course Content

• Project setup, gap analysis, and MedTech QMS scope
• Context, leadership, and quality policy in MedTech
• Design and development controls + ISO 14971
• Production, validation, and traceability
• CAPA, complaints, and adverse event reporting
• Post-market surveillance and vigilance
• Internal audit and management review
• Certification readiness, FDA inspection, and EU MDR notified body audits

Methodology

A workshop-led course combining trainer presentations, group exercises, case studies, and template-driven document development across the four days.

Assessment

Continuous assessment through implementation exercises and a final written assessment.

Certificate

Prerequisites