30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor
Credit hours
3
Learn how ISO 14971:2019 applies risk management to medical devices and how such systems are audited. Units cover key terminology, hazard identification and risk analysis, risk controls, documentation, corrective actions, and continual improvement. Suited to quality, regulatory and engineering professionals in the medical device sector who take part in or prepare for audits.
What you'll cover
- 01Introduction to ISO 14971:2019 – Risk Management for Medical Devices
- 02Risk Management Process Overview and Terminology
- 03Risk Analysis: Identifying Hazards and Assessing Risks
- 04Risk Control Measures and Mitigation Strategies
- 05Auditing Risk Management Systems for Compliance
- 06Documentation Requirements and Record Keeping in Risk Management
- 07Corrective Actions and Risk Management Audits
- 08Continual Improvement and Monitoring of Risk Management Systems
More in ISO Lead Auditor
- ISO Lead Auditor
30-Hours ISO 15189:2022 – Medical Laboratories Quality Assurance & Competence
Focused on ISO 15189:2022, these units explain how medical laboratories manage quality and competence. Learners study the standard's key clauses, quality management…
View course - ISO Lead Auditor
30-Hours ISO 22000:2018 Food Safety Management System (FSMS) Lead Auditor
Explore the requirements of ISO 22000:2018 and how a food safety management system is audited. Learners study key concepts and terminology, the audit process, planning…
View course - ISO Lead Auditor
ISO 14001:2015 EMS Lead Auditor Course – 40 Hours
Covering environmental management systems and the requirements of ISO 14001:2015, this course teaches the principles and techniques of auditing. Learners work through…
View course
30-Hours ISO 14971:2019 – Risk Management Application on Medical Devices Lead Auditor