FDA QMSR Implementation

Delivered as a live virtual training via Zoom, this course is  designed for Quality Management (QMS) professionals transitioning to the new framework globally, including teams across the UK, Europe, and the US. This course is proudly developed and delivered out of Galway, Ireland, one of Europe’s premier global medical technology clusters.”

This live virtual training programme provides medical device professionals with a practical understanding of the transition from FDA’s Quality System Regulation (QSR – 21 CFR Part 820) to the Quality Management System Regulation (QMSR).

With FDA QMSR in effect from 2 February 2026, organisations must understand the structural and terminology changes introduced through alignment with ISO 13485 concepts, and assess how these changes may impact their existing Quality Management System.

This course will help participants:

• Understand the regulatory intent behind the transition
• Identify key structural and terminology differences
• Recognise QMS processes and documentation areas that may require review
• Apply a structured approach to gap assessment and transition planning
• Develop a practical internal action list

The training focuses on interpretation of the published regulation and practical implementation considerations. It provides structured regulatory education and preparation guidance.

By the end of the course participants will be able to:

• Explain the regulatory rationale for FDA’s transition from QSR to QMSR
• Describe the structural and terminology differences between 21 CFR Part 820 and QMSR
• Interpret key QMSR changes in practical implementation terms
• Identify QMS processes, procedures and documentation areas that may require internal review
• Apply a structured framework for conducting a QMSR gap assessment
• Outline a practical, prioritised transition action plan suitable for their organisation

This course is designed for professionals involved in Quality Management Systems (QMS) and regulatory compliance within medical device organisations transitioning from FDA QSR to QMSR.

It is particularly suitable for:

• Quality Managers and Engineers
• Regulatory Affairs professionals
• QMS Process Owners
• CAPA and Supplier Quality personnel
• Document Control and Training Coordinators
• Internal Auditors
• CSV / Validation stakeholders
• Operations or Manufacturing leaders involved in QMS processes

Ideal for organisations that:

• Operate under 21 CFR Part 820
• Hold ISO 13485 certification
• Are actively planning QMSR transition activities

Participants should have a working understanding of their organisation’s QMS. No specialist ISO 13485 expertise is required.

Dr. Fiona Masterson

Dr. Fiona Masterson is an experienced quality and operations management professional with over 25 years in regulated manufacturing, including extensive work in the medical device sector.

She has worked extensively with FDA’s Quality System Regulation (21 CFR Part 820), supporting organisations through inspections, remediation programmes, and regulatory observations, including Form 483 responses.

Fiona holds a Doctorate in Mechanical Engineering and combines practical industry expertise with academic insight. She specialises in delivering structured, implementation-focused training for professionals operating in regulated environments.