ISO 14971:2019 - Certified Lead Auditor
Exam Code: ISO-14971-LA
The ISO 14971:2019 – Certified Lead Auditor certification is designed for professionals seeking to develop the expertise required to plan, conduct, lead, and manage audits of risk management systems for medical devices. Based on ISO 14971:2019, the certification focuses on the application of risk management principles throughout the medical device life cycle, including risk analysis, risk evaluation, risk control, and monitoring of production and post-production information. It covers auditing risk management processes, evaluating compliance with applicable requirements, identifying nonconformities, preparing audit reports, and verifying corrective actions. This certification is suitable for quality assurance professionals, medical device manufacturers, regulatory affairs specialists, risk management professionals, consultants, and auditors involved in medical device safety, quality management, and regulatory compliance.
ISO 14971:2019 outlines a framework for applying risk management to medical devices. It emphasizes identifying, evaluating, and controlling risks throughout a device's lifecycle, ensuring patient safety. The standard guides manufacturers in making informed decisions, balancing benefits and risks, and complying with regulatory requirements to enhance healthcare outcomes.
The ISO 14971:2019 - Certified Lead Auditor course is typically designed for professionals involved in the medical device industry, particularly those responsible for quality management systems and risk management.
