ISO 14971:2019 Medical Devices Lead Auditor

This ICTQual AB Lead Auditor course focuses on ISO 14971:2019 risk management for medical devices, audit planning, audit execution, compliance evaluation, documentation review, corrective action, and continual improvement.

• Covers ISO 14971:2019 risk management principles for medical devices

• Develops lead auditing skills for planning, conducting, reporting, and follow-up

• Focuses on risk analysis, risk evaluation, risk control, and residual risk review

• Includes medical device regulatory compliance and ISO 13485 relationship awareness

• Emphasizes risk management documentation, traceability, and audit evidence

• Includes mandatory assessment through ICTQual AB Approved Training Centres

The ISO 14971:2019 Medical Devices Lead Auditor course is designed for professionals who need to audit and evaluate risk management processes applied to medical devices. It supports understanding of hazard identification, risk estimation, risk evaluation, risk control, and monitoring of control effectiveness across the device lifecycle.

• Understand ISO 14971:2019 in the context of medical device safety and effectiveness

• Evaluate risk management processes used throughout the medical device lifecycle

• Assess risk management files, plans, reports, and supporting documentation

• Apply audit principles, techniques, and methods to ISO 14971:2019 audits

• Identify nonconformities, audit findings, risks, and improvement opportunities

• Support corrective action, compliance improvement, and continual risk management enhancement

Learners will develop the knowledge and competence to audit ISO 14971:2019 medical device risk management processes, documentation, controls, compliance arrangements, and continual improvement activities.

• Understand the purpose, scope, terminology, and principles of ISO 14971:2019

• Explain the risk management process for medical devices throughout the product lifecycle

• Identify hazards and assess risks associated with medical device safety and performance

• Evaluate risk control measures, residual risk, benefit-risk decisions, and monitoring activities

• Review ISO 14971 documentation including risk management plans, files, and reports

• Lead ISO 14971:2019 audits, report findings, and support corrective action follow-up

This course is intended for professionals involved in medical device risk management, quality assurance, regulatory compliance, auditing, product development, and safety assurance who need lead auditor competence.

• Medical device quality managers and quality assurance professionals

• Regulatory affairs specialists working with medical device compliance

• Internal auditors, supplier auditors, and lead auditor candidates

• Risk managers and compliance officers in medical device organizations

• Engineers, product designers, and technical personnel involved in device lifecycle activities

• Consultants, trainers, and professionals supporting ISO 14971 or ISO 13485 systems

Participants should have a suitable educational or professional background and basic understanding of medical device quality, risk management, regulatory compliance, or auditing principles.

• A degree, equivalent qualification, or relevant professional experience in engineering, life sciences, healthcare, medical devices, quality, regulatory affairs, or auditing is recommended

• Familiarity with ISO 14971:2019, ISO 13485, medical device development, regulatory requirements, or quality management systems is beneficial

Assessment is conducted through ICTQual AB Approved Training Centres to evaluate understanding of course content and the ability to apply ISO 14971:2019 and auditing concepts in practical situations.

• Multiple-choice questions to assess knowledge of ISO 14971:2019 and auditing principles

• Scenario-based questions to evaluate practical application of risk management concepts

• Review of audit-related understanding including planning, evidence collection, reporting, and follow-up

• Minimum passing requirement as specified by ICTQual AB Approved Training Centre assessment arrangements

Successful completion supports professional progression in medical device risk management, quality assurance, regulatory compliance, auditing, consulting, and advanced medical device standards training.

• Progress to medical device quality, risk management, regulatory affairs, or compliance leadership roles

• Pursue ISO 13485 Lead Auditor or other medical device management system audit training

• Advance into supplier auditing, internal auditing, external auditing, or consulting roles

• Continue professional development in medical device regulation, post-market surveillance, and quality systems