Medical Device Quality Management Systems Training

Struggling to reduce the burden of compliance while building a quality system that truly supports your organisation? This two-day on-site + half-day online course gives you the clarity and tools to implement and maintain a robust Quality Management System (QMS) that meets EU and US regulatory expectations.

You’ll gain a deep understanding of ISO 13485:2016, Medical Device Regulation (MDR), In Vitro Diagnostic Regulation (IVDR), and FDA Quality System Regulation, 21 CFR Part 820 (QSR), and learn how to apply a pragmatic, risk-based approach to critical QMS elements—from design control and change management to audits and post-market surveillance.

Whether you’re starting from scratch or improving an existing system, this course equips you to make your QMS both compliant and effective.

Learning outcomes

Participants will learn how to:

• Implement and maintain a QMS in line with ISO 13485:2016, QSR, and MDR/IVDR.
• Evaluate QMS effectiveness using Internal Audits, Management Review, and CAPA.
• Integrate risk management into QMS processes, especially during change control.
• Perform efficient supplier control and determine when and how to audit suppliers.

Course content

The course covers:

Module 1 – QMS Essentials & Regulatory Scope 
Clarify the purpose and scope of a QMS under ISO 13485, MDR/IVDR, and QSR.

Module 2 – Risk-Based QMS Management 
Apply Plan SO Check Act (PDCA) and risk-based thinking to structure and maintain an effective QMS.

Module 3 – Design Control & Change Management 
Implement design control and manage changes with regulatory alignment and traceability.

Module 4 – Supplier & Outsourcing Controls 
Define supplier requirements, apply appropriate controls, and plan supplier audits.

Module 5 – Monitoring & Continuous Improvement 
Use audits, CAPA, and management reviews to evaluate and improve your QMS.

Module 6 – Global Compliance & Post-Market Readiness 
Address key differences between ISO 13485 and QSR, and ensure MDR/IVDR compliance post-market.

Target audience

This course is ideal for professionals working in R&D, production, process development, or quality assurance within the medical device industry—especially those involved in implementing, maintaining, or auditing a QMS.
It is also relevant for anyone needing a deeper understanding of ISO 13485, MDR/IVDR, and the QSR.

For continued professional development, this course can be combined with our advanced Auditor/Lead Auditor training.

Prerequisites

Participants should have:

• Basic understanding of quality systems (e.g. ISO 13485 principles or equivalent internal training)
• 6–12 months of experience in the medical device industry or a similar regulated environment

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