ICTQual Level 3 Award in ISO 14971:2019

This qualification introduces internationally recognised risk management principles for medical devices based on ISO 14971:2019 requirements and industry best practices.

• Internationally aligned ISO 14971:2019 curriculum

• Comprehensive understanding of medical device risk management

• Practical focus on hazard identification and risk control

• Covers regulatory compliance and lifecycle risk management

• Suitable for healthcare and medical device professionals

• Supports progression into auditing and compliance roles

The ICTQual Level 3 Award in ISO 14971:2019 is designed to provide learners with a strong foundation in the application of risk management principles to medical devices. The qualification focuses on ISO 14971:2019 requirements, helping learners understand how to identify hazards, analyse risks, implement control measures, and maintain compliance throughout the medical device lifecycle.

• Understand ISO 14971:2019 risk management principles

• Develop knowledge of medical device safety requirements

• Learn practical risk analysis and control techniques

• Explore regulatory frameworks for medical devices

• Understand lifecycle-based risk management approaches

• Improve professional competence in healthcare compliance

Learners will gain knowledge and practical understanding of medical device risk management processes aligned with ISO 14971:2019 requirements.

• Understand the purpose and scope of ISO 14971:2019

• Explain the importance of risk management in medical devices

• Apply risk management principles throughout device lifecycles

• Identify hazards and evaluate medical device risks

• Implement suitable risk control measures and monitoring activities

• Understand regulatory compliance and post-market surveillance requirements

This qualification is suitable for learners seeking knowledge and skills in medical device risk management, regulatory compliance, and healthcare quality systems.

• Medical device manufacturing professionals

• Quality assurance and compliance personnel

• Regulatory affairs professionals

• Healthcare technology professionals

• Internal auditors and risk management staff

• Learners pursuing careers in healthcare compliance

Entry requirements may vary by training provider; however, learners are expected to possess basic educational qualifications and sufficient English language proficiency.

• Basic understanding of healthcare, engineering, or quality management concepts

• Ability to read, write, and communicate effectively in English

Learners are assessed through practical and knowledge-based evaluation methods designed to measure understanding of ISO 14971:2019 principles and risk management practices.

• Written assignments and assessments

• Practical case study evaluations

• Knowledge-based questioning

• Internal assessment and verification

Successful learners can progress into advanced qualifications and professional roles related to quality assurance, regulatory affairs, and medical device compliance.

• Advanced ISO lead auditor qualifications

• Higher-level healthcare compliance qualifications

• Medical device quality management roles

• Regulatory affairs and risk management careers