LAPT
London Academy of Professional Training
Master Certificate
Level 6-7
Leadership
ISO Security Safety & Risk
ISO 14971RSK — Medical Device Risk Management
REF: SSR-RSK-14971RSK
Prerequisites
None
Awarding Body: LAPT — London Academy of Professional Training
Curriculum Overview
1
Regulatory Compliance and Auditing
Understanding ISO 14971: Framework for Medical Device Risk Management
Regulatory Compliance Requirements in Risk Management for Medical Devices
Risk Assessment Processes: Identifying and Evaluating Risks
Risk Control Measures: Implementing Strategies to Mitigate Risks
Auditing for Compliance: Tools and Techniques for ISO 14971
2
Implementation of Risk Controls
Understanding Risk Controls in Medical Device Management
Identifying and Evaluating Risks in Medical Devices
Developing Effective Risk Control Measures
Implementing and Monitoring Risk Controls
Continuous Improvement and Regulatory Compliance for Risk Management
3
Developing Risk Management Plans
Fundamentals of Risk Management in Medical Devices
Identifying Hazards and Assessing Risks
Developing Risk Management Plans: Framework and Requirements
Implementing Risk Control Measures
Monitoring and Reviewing Risk Management Processes
4
Risk Analysis Techniques
Foundations of Risk Analysis in Medical Devices
Identifying Hazards and Assessing Risks
Qualitative Risk Analysis Methodologies
Quantitative Risk Assessment Techniques
Implementing Risk Control Strategies and Monitoring
5
ISO 14971 Standards Overview
Fundamentals of ISO 14971: Understanding Risk Management Principles
Risk Management Process: Phases and Activities in ISO 14971
Risk Analysis Techniques: Tools and Methods for Medical Devices
Risk Evaluation and Mitigation: Strategies for Compliance
Post-Market Surveillance and Continuous Risk Management under ISO 14971
6
Fundamentals of Risk Management
Fundamental Concepts of Risk Management in Medical Devices
Identifying and Analyzing Risks in Medical Devices
Implementing Risk Controls and Mitigation Strategies
Monitoring and Reviewing Risk Management Processes
Integrating Risk Management into Quality Management Systems
Assessment Breakdown
Passing Mark: 325 / 500 (65%)
How to Enrol
Website: lapt.org
Email: info@lapt.org
Phone: +44 7513 283044
Address: 85 Great Portland Street, W1W 7LT, United Kingdom
Hours: Monday – Friday, 9AM – 5PM