Risk Management Systems - Successfully Implementing the Requirements of ISO 14971 and MDR/IVDR
This course provides a comprehensive and practice oriented introduction to implementing a compliant Risk Management System (RMS) according to ISO 14971 and the MDR/IVDR as well as FDA QMSR aspects. Participants gain a clear understanding of legal and normative requirements, learn how to structure and maintain a complete risk management file, and explore practical methods for risk analysis, risk control, and lifecycle long risk evaluation. Drawing on first hand insights from the ISO standards committee, the training explains the background and intent behind ISO 14971 and ISO/TR 24971, and demonstrates how risk management interfaces with clinical evaluation, usability engineering, cybersecurity, and biological safety.
Course Outline
- Regulatory foundations for risk management
- ISO 14971 structure, terminology, and process requirements
- Risk management file structure and documentation
- Verification and validation of risk control measures
- Lifecycle long risk management and post market surveillance
- Interfaces with clinical evaluation, usability, cybersecurity, and biological safety
- ISO/TR 24971 guidance and harmonization status
- Practical examples and implementation strategies
Course Tutor
Dr. Norman Kaufmann is a Senior Regulatory Affairs Manager with extensive experience in Regulatory Affairs, Quality Management, and Clinical Evaluation of medical devices. Following doctoral research at the Technical University of Braunschweig on the development of a biocatalytic process for the industrial production of D-lactic acid from renewable resources, he specialized in regulatory compliance and quality assurance throughout the entire medical device lifecycle.
His areas of expertise include the implementation and maintenance of Quality Management Systems in accordance with ISO 13485, ISO 9001, and the European Medical Device Regulation (EU) 2017/745 (MDR), as well as ensuring product compliance with applicable regulatory requirements. He is experienced in preparing Clinical Evaluation Reports and conducting biological evaluations in line with the ISO 10993 series and FDA guidance.
In addition, Dr. Kaufmann has extensive experience in Post-Market Surveillance, Vigilance, CAPA and Change Management processes, as well as supporting audits conducted by Notified Bodies and Competent Authorities. As a trainer, he delivers practical training on key regulatory and quality management standards, including ISO 13485, ISO 14971, and the ISO 10993 series.
He also served as Coordinator and Technical Expert in the European CASP Corona 2020 project, working with the European Commission and EU Market Surveillance Authorities to assess the compliance of SARS-CoV-2 consumer protection products. His profile is further complemented by experience in international OEM partnerships and the negotiation of Quality Assurance Agreements.
Learning Outcomes
Introduction to Regulatory Requirements for Risk Management
- Overview of regulatory expectations
- Legal requirements under MDR (EU) 2017/745
- Legal requirements under IVDR (EU) 2017/746
- FDA QMSR risk based approach
Risk Management System (RMS) According to ISO 14971 and MDR/IVDR
- Key terms, abbreviations, and definitions
- Structure and requirements of the risk management process
- Integration of risk management into the QMS
Risk Management File: Structure and Content
- Required documentation elements
- Risk management plan, risk analysis, risk evaluation, risk control, and risk report
- Practical example of a complete risk management workflow
Implementation, Verification, and Validation of Risk Control Measures
- Methods for verifying and validating risk controls
- Information from production and post production phases
- Continuous risk management throughout the product lifecycle
Interfaces to Other Regulatory and Normative Requirements
- Usability engineering according to IEC 62366-1
- Cybersecurity activities according to IEC 81001-5-1
- Biological evaluation according to ISO 10993-1
- Benefit–risk analysis and its connection to clinical evaluation
Current Standardization Status
- Overview of ISO/TR 24971
- Harmonization and interpretation guidance
Who Should Attend
- Manufacturers of medical devices and in vitro diagnostics
- Authorized Representatives, Importers and Distributers
- Risk managers and members of risk management teams
- Regulatory Affairs Managers / Specialists
- Clinical Affairs Managers
- Quality Management Representatives
- Persons Responsible for Regulatory Compliance
- Post-market Surveillance (PMS) Managers / Specialists
- Complaint Handling and CAPA Managers
- Auditors
Why You Should Attend
This course is ideal for professionals who need a clear and actionable understanding of risk management under ISO 14971 and MDR/IVDR as well as the FDA QMSR. It equips participants to build a robust RMS, maintain complete and audit ready documentation, and integrate risk management into development, production, and post market processes. Practical examples and implementation tools help organizations ensure compliance and strengthen product safety and performance throughout the lifecycle.
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AI in Medical Devices - Expectations in a Maturing Field
Biological Evaluation of Medical Devices - How to Succeed in Your Notified Body Assessment
CAPA Considerations: A Comprehensive Overview
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