An Introduction To Risk Management ISO 14971:2019 Training Course: Learn To Review And Build Documentation To Meet Quality And Regulatory Standards (Nov 11, 2025)

(MENAFN- GlobeNewsWire - Nasdaq) The medical device industry's shift towards risk-based regulatory compliance presents key opportunities. Mastery of ISO 14971:2019 enables enhanced risk management documentation and regulatory adherence. Comprehensive training like Linda Garrod's course offers vital skills for navigating these evolving requirements.

Dublin, Sept. 29, 2025 (GLOBE NEWSWIRE) -- The "An introduction to Risk Management ISO 14971:2019 Training Course (Nov 11, 2025)" training has been added to ResearchAndMarkets's offering.

Understand the use of risk management in the medical device industry and how to review and construct risk management documentation to meet both quality and regulatory requirements.

The global regulation of medical devices is increasingly taking the risk based approach, whether that be when building a quality management system or building technical documentation for registrational submissions. ISO 14971:2019 is the international standard which supports the assessment of risks and construction of compliant risk management documentation to support these areas.

Linda Garrod of IVDeology has developed the course to provide participants with foundational knowledge and practical skills related to the application of ISO14971:2019, an international standard for medical device risk management.

Key topics to be addressed:

• Overview of ISO14971:2019
• Risk management framework
• Risk management planning
• Risk analysis techniques
• Risk evaluation and acceptability
• Risk control measures
• Documentation and record keeping
• Risk management throughout the product lifecycle
• Compliance with regulatory requirements

Benefits of attending

• Understand the use of a risk-based approach and how ISO14971 supports this
• Gain a clear understanding of ISO14971 content and the use of key terminology
• Review each step In the risk management pathway to fully understand expected analysis and content
• Be able to identify the content expected for each type of risk management record
• Understand the use of well constructed risk management documentation to support post market device analysis and complaint handling

Certifications:

• CPD: 3 hours for your records
• Certificate of completion

Who Should Attend:

• Medical device managers who must sign off on risk management files
• Regulatory professionals
• Quality specialists
• Research and development scientists
• Manufacturers
• Clinical support team members

Key Topics Covered:

What is risk management?

ISO 14971 standard and risk management planning

• Introduction to the ISO standard and its significance in the medical device industry and basic principles of risk management
• Understanding the fundamental principles of risk management as outlined in ISO
• Identification of key terms, definitions and concepts related to risk.
• Guidelines for developing a risk management plan in accordance with the ISO
• Determining the scope of risk management activities and establishing objectives
• Clarification of roles and responsibilities within the context of risk management
• Discussion on the involvement of different stakeholders in the risk management process
• Guidance on how the ISO aligns with regulatory requirements for medical devices
• Ensuring that risk management practices comply with applicable international regulations

Risk assessment

• Criteria for evaluating and assessing risks.
• Determining acceptable risk levels and making risk acceptability decisions

Risk controls

• Strategies for implementing risk control measures to reduce or eliminate identified risks.
• Integration of risk controls into the design and development process

Benefit-risk analysis

• Intro to various risk analysis techniques prescribed by the ISO.
• Practical application of risk analysis methods, such as hazard analysis, fault tree analysis and failure mode and effects analysis

Risk management report & post-production activities

• Requirements for documenting and maintaining records of the risk management process.
• Best practices for creating comprehensive documentation that meets regulatory standards.
• Understanding the application of risk management at various stages of the medical device lifecycle
• Incorporating risk management into design, manufacturing, post-market surveillance and other phases

Speakers:
Linda Garrod
Ivdeology
Linda Garrod is a Quality Specialist at IVDeology Ltd, based in Kent, UK. She brings her exceptional quality experience from 20 years within the medical device industry, to support manufacturers in the creation and continual improvement of Quality Management Systems, compliant with the demands of ISO 13485, MDSAP and CE IVDR.
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