ICTQual ISO 14971:2019 Medical devices – Application Of Risk Management To Medical Devices ISO Internal Auditor
This ICTQual AB course develops internal auditing skills for ISO 14971:2019 medical device risk management, covering hazards, risk controls, documentation, regulatory compliance, and continuous improvement.
Course Features
This ICTQual AB ISO Internal Auditor course focuses on ISO 14971:2019 medical device risk management, internal auditing principles, regulatory compliance, official study units, mandatory assessment, and Approved Training Centre delivery.
- ICTQual AB ISO Internal Auditor course focused on ISO 14971:2019 medical device risk management
- Covers hazard identification, risk estimation, risk evaluation, risk control, and monitoring of control effectiveness
- Includes internal auditing principles, audit planning, audit conduct, reporting findings, and corrective action follow-up
- Structured around the official ICTQual AB study units for ISO 14971:2019 Medical Devices Internal Auditor
- 5-day training program delivered through ICTQual AB Approved Training Centres
- Mandatory assessment through 100 multiple-choice questions with a minimum passing score of 75%
About This Course
The ICTQual ISO 14971:2019 Medical Devices Internal Auditor course is designed for professionals involved in medical device risk management, quality assurance, regulatory compliance, and internal auditing. It addresses the application of ISO 14971:2019 as a systematic framework for identifying hazards, estimating and evaluating associated risks, controlling risks, and monitoring control effectiveness.
Understand the purpose, scope, and importance of ISO 14971:2019 for medical devices
Apply risk management principles to medical device safety, performance, and usability concerns
Recognize the relationship between ISO 14971:2019, regulatory requirements, and quality management systems
Plan, conduct, and report internal audits against ISO requirements
Review risk management documentation for accuracy, completeness, and traceability
Support corrective actions, ethical decision-making, and continuous improvement in risk management processes
What You'll Learn
Learners will develop the knowledge required to understand ISO 14971:2019, apply medical device risk management principles, and perform internal auditing activities in line with ICTQual AB course outcomes.
Understand the purpose, scope, terminology, and compliance importance of ISO 14971:2019
Describe risk management principles, processes, hazard identification, risk assessment, risk control, evaluation, and review
Analyze medical device-specific risks, regulatory requirements, industry best practices, safety, performance, and usability concerns
Apply ISO internal auditing principles, techniques, methodologies, audit planning, audit conduct, and reporting practices
Develop implementation strategies for ISO 14971 risk management processes, documentation, and quality management system integration
Use risk analysis techniques, documentation controls, regulatory compliance, continuous improvement, and ethical principles in medical device risk management
Who Should Attend?
This course is designed for individuals involved in the medical device industry who are responsible for risk management, quality assurance, regulatory compliance, internal auditing, engineering, or compliance activities.
Quality managers working in medical device organizations
Regulatory affairs specialists involved in medical device compliance
Risk managers responsible for medical device risk management processes
Internal auditors assessing ISO and regulatory conformity
Engineers involved in medical device design, development, manufacturing, or lifecycle activities
Compliance officers supporting medical device quality, safety, and regulatory systems
Course Content
Explore the comprehensive ICTQual ISO 14971:2019 Medical devices – Application Of Risk Management To Medical Devices ISO Internal Auditor course content designed to help you master the material through structured modules and lessons.
Fundamentals of Risk Management
Risk Management in Medical Devices
ISO Internal Auditing Principles
ISO 14971 Implementation
Risk Analysis Techniques
ISO 14971 Documentation Requirements
Role of the ISO Internal Auditor
Regulatory Compliance and Standards
Continuous Improvement in Risk Management
Ethical Considerations in Risk Management
Course Requirements
Entry requirements may vary by institution, but ICTQual AB identifies typical requirements related to education, technical background, professional experience, ISO 13485 familiarity, and English language proficiency.
A bachelor’s degree or equivalent is typically required, preferably in engineering, life sciences, healthcare, or a related field; equivalent professional experience may also be acceptable
Familiarity with ISO 13485, relevant medical device industry experience, and proficient English language skills are advantageous for effective participation
Assessments
Assessment is mandatory and is conducted through ICTQual AB Approved Training Centres to evaluate understanding of the course material and the ability to apply concepts in practical situations.
Mandatory assessment conducted through Approved Training Centres
Quiz-based assessment consisting of 100 multiple-choice questions
Assessment evaluates comprehension of course material and practical application of concepts
Minimum passing score of 75% is required
Progression
Completion of this course supports progression into advanced certifications, specialist medical device risk management roles, leadership positions, and advisory responsibilities in quality, regulatory, and compliance functions.
Advanced certifications in risk management, quality assurance, regulatory affairs, Certified Quality Auditor, ISO 13485 Lead Auditor, or medical device regulation
Specialization in medical device risk management areas such as cybersecurity risk management, software risk management, or device-specific risk management
Leadership roles such as risk manager, quality manager, regulatory affairs manager, or director of compliance
Consulting and advisory roles providing expertise in risk management, regulatory compliance, and quality assurance
Apply Now For This Course
Fill out the application form below to enroll in ICTQual ISO 14971:2019 Medical devices – Application Of Risk Management To Medical Devices ISO Internal Auditor. Our team will review your application and contact you shortly with enrollment details.
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