Medical Device Quality Management Systems Training

Learn how to effectively implement and maintain a quality management system in line with the requirements in ISO 13485:2016, EU MDR/IVDR, and US FDA QSR (21 CFR Part 820)

*MDR – EU Medical Device Regulation
**QSR (QS Reg) – US Medical Device Regulation, 21 CFR 820

Course description:

Struggling to maintain compliance while building a robust quality management system (QMS) for medical devices? This comprehensive training course is designed to help professionals implement and optimize a QMS aligned with ISO 13485:2016, EU MDR/IVDR, and US FDA QSR (21 CFR Part 820) requirements.

Through a risk-based, structured, and pragmatic approach, you’ll gain the skills to manage critical QMS elements such as design control, supplier management, process validation, CAPA, internal audits, and post-market surveillance.

Key Topics Covered

• ISO 13485:2016 requirements and implementation strategies
• EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR)
• US FDA Quality System Regulation (QSR), 21 CFR Part 820
• Risk management integration across the product lifecycle
• Design and development controls
• Supplier and outsourcing controls
• Process validation and QMS software validation
• CAPA system and change control
• Internal audits and management reviews
• Post-market surveillance and feedback mechanisms

Learning objectives

Participants will learn how to:

• Implement a compliant and effective Medical Device QMS based on ISO 13485, MDR/IVDR, and QSR (21 CFR Part 820).
• Evaluate QMS performance using tools like CAPA, internal audits, and management reviews.
• Apply a risk-based approach to quality system processes and decision-making.

Course outline

Day 1- Foundations and Regulatory Framework

• Setting scope and objectives, impact of the legal role and stakeholder relations
• Medical Device Regulations in EU and US – requirements not covered by ISO13485.
• PDCA and risk-based approach
• Product development (design control)
• Risk management, in development phase and during the product lifecycle
• Supplier control and outsourcing
• Document controls; interrelations and traceability

Day 2- Operational Excellence and Continuous Improvement

• Production processes and validation, incl validation of QMS software validation
• Product and process monitoring – data analysis
• Preventive and corrective actions – the CAPA system
• Change control – determine the risk and set objectives
• Management review – finding the right level of detail for input, and deliverables.
• Internal audits – plan, perform and follow-up
• Upcoming changes; the impact of QMSR (FDA’s transition to ISO13485:2016)

Who should attend

The course is suitable for persons working with Regulatory Affairs, Research & Development (R&D), Manufacturing and Process Development or Quality Assurance (QA) who is involved in or responsible for, the operation or audit of a Quality Management System (QMS) for medical devices. Individuals wanting knowledge about the US Quality System Regulation (QS Reg) as well as the ISO 13485 standard and the relation to the Medical Device regulations (MDR/IVDR) will also benefit from this course.

Prerequisites

Participants should have:

• Basic knowledge of quality systems, e.g. by participating in one of our basic courses or have equivalent knowledge of the company’s internal quality assurance programs.
• 6–12 months of experience in the regulated medical device industry

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