ICTQual ISO 14971:2019 Medical Devices Foundation
This foundation course develops essential knowledge of ISO 14971:2019 risk management principles for medical devices, supporting patient safety, lifecycle risk control, and regulatory compliance.
Course Features
This ICTQual AB foundation course introduces ISO 14971:2019 medical device risk management through structured study units, mandatory assessment, flexible delivery through approved centres, and practical knowledge for healthcare technology safety.
- ICTQual AB foundation-level training focused on ISO 14971:2019 medical device risk management
- Covers risk identification, analysis, evaluation, control, monitoring, review, and lifecycle integration
- Designed for professionals involved in medical device development, quality, compliance, healthcare, and auditing
- Offered through approved training centres in online, in-person, or blended formats subject to ATC decision
- Includes mandatory assessment to verify understanding and practical application of course concepts
- Supports patient safety, regulatory awareness, and effective medical device risk management practice
About This Course
The ICTQual ISO 14971:2019 Medical Devices Foundation course is designed to equip participants with knowledge and skills required to understand risk management in medical device development and use. It introduces ISO 14971:2019 as a framework for identifying, analysing, evaluating, controlling, monitoring, and reviewing risks across the medical device lifecycle.
Provides a foundation in ISO 14971:2019 and its role in medical device safety
Explains risk management requirements throughout the medical device lifecycle
Builds understanding of hazard identification, risk analysis, risk evaluation, and risk control
Supports awareness of regulatory frameworks and compliance requirements for medical devices
Connects risk management with design, manufacturing, usage, post-market surveillance, and continual improvement
Prepares learners for further professional development in medical device risk management and compliance
What You'll Learn
Learners will develop foundation-level understanding of ISO 14971:2019, medical device risk management processes, regulatory expectations, risk analysis techniques, control measures, lifecycle integration, and emerging industry issues.
Understand the purpose and scope of ISO 14971:2019 in the context of medical devices
Explain the importance of risk management in ensuring the safety and effectiveness of medical devices
Recognize regulatory requirements related to risk management for medical device manufacturers
Outline and apply the lifecycle approach to risk management prescribed by ISO 14971:2019
Identify hazards, evaluate risks, prioritize risks, and select suitable risk control measures
Explain monitoring, review, continual improvement, and integration of risk management into the device lifecycle
Who Should Attend?
This course is suitable for professionals involved in medical device design, development, manufacturing, quality, regulatory compliance, clinical research, healthcare delivery, risk management, compliance, and auditing.
Product designers and engineers involved in medical device development
Quality assurance professionals working with medical device systems and processes
Regulatory affairs professionals responsible for medical device compliance
Medical device manufacturers and technical staff involved in lifecycle risk management
Clinical researchers, healthcare providers, and professionals involved in device use or evaluation
Risk management specialists, compliance officers, and auditors working in the medical device industry
Course Content
Explore the comprehensive ICTQual ISO 14971:2019 Medical Devices Foundation course content designed to help you master the material through structured modules and lessons.
Regulatory Framework and Compliance Requirements
Risk Management Process According to ISO 14971:2019
Risk Analysis Techniques
Risk Control Measures and Implementation
Monitoring and Review of Risk Management Activities
Integration of Risk Management into the Device Lifecycle
Future Trends and Emerging Issues
Course Requirements
Entry requirements may vary by institution, but learners are generally expected to have relevant interest, professional background, or basic knowledge related to medical devices, standards, quality management, or regulatory requirements.
Basic understanding of medical device development, regulatory requirements, and quality management principles is beneficial
Proficient English language skills are required to engage with course materials, discussions, written assignments, and assessments
Assessments
The course includes mandatory assessment through approved training centres, using quizzes consisting of multiple-choice questions to evaluate understanding and practical application of the course material.
Mandatory assessment conducted through approved training centres
Quiz-based assessment consisting of 100 multiple-choice questions
Evaluation of comprehension of course material and practical application of concepts
Minimum passing score of 75% required
Progression
Completion of this foundation course supports further professional development in medical device risk management, regulatory compliance, quality management systems, auditing, and specialist ISO 14971-related roles.
Progression to advanced medical device risk management training and certification programmes
Progression to ISO 14971 implementation, internal auditing, or lead implementer training
Career development in medical device quality assurance, regulatory affairs, compliance, and risk management
Continued development in medical device lifecycle management, post-market surveillance, and quality management systems
Apply Now For This Course
Fill out the application form below to enroll in ICTQual ISO 14971:2019 Medical Devices Foundation. Our team will review your application and contact you shortly with enrollment details.
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