Change Management in Practice - Selected Practical Examples for Evaluating Changes
This course provides a clear and practice oriented introduction to change management for medical device manufacturers. Participants learn how to evaluate, control, and document changes in compliance with ISO 13485, the EU MDR, 21 CFR 820 and other global key markets. Using practical examples, the training illustrates how product and process changes are assessed, how risks are managed, and how regulatory classifications are performed. The course builds a deep understanding of change workflows, interfaces, strategies and responsibilities to ensure continuous conformity and regulatory compliance.
Course Outline
- Regulatory framework for change management (ISO 13485, MDR, 21 CFR 820, int. requirements)
- Types of changes and terminology
- Evaluation of product and process changes
- Risk based change assessment aligned with ISO 14971
- Integration of CAPA processes
- Supplier involvement and contractual requirements
- Regulatory classification of significant changes
- Use of PMS/PMCF data and production trends
- Practical examples of change evaluation and documentation
Learning Outcomes
Apply Regulatory Requirements with Confidence
- ISO 13485
- Regulation (EU) 2017/745 (EU MDR)
- 21 CFR 820 (Quality System Regulation)
- International requirements
Implement Change Management in Practice
- Understanding terminology, definitions, and typical types of changes
- Evaluating and tracing changes during development and post market phases
- Handling product and process changes using real world examples
- Applying the risk based approach in accordance with ISO 14971
- Integrating corrections, corrective actions, and preventive actions (CAPA)
Manage Interfaces and Responsibilities
- Effective collaboration across development, quality, regulatory affairs, purchasing, and suppliers
- Understanding requirements for agreements with suppliers and subcontractors
- Communicating with Notified Bodies and authorities regarding significant changes
Use Data Analysis and Trends
- Evaluating trends and feedback from PMS/PMCF activities
- Deriving change needs from quality and production data
Who Should Attend
Why You Should Attend
- This course is ideal for professionals who need to evaluate and manage changes in a structured, traceable, and compliant manner. It equips participants to apply regulatory requirements confidently, integrate risk management and CAPA processes, and classify changes from a regulatory perspective. Practical examples help translate theory into daily practice and prepare participants for effective communication with Notified Bodies and authorities.
Who Should Attend
- Medical device manufacturers
- Regulatory Affairs professionals
- Quality Management specialists
- Research and Development teams
- Suppliers and subcontractors
- Purchasing departments
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