📄 ISO 14971 — Risk Management for Medical Devices — Certification Brochure
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IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 14971 — Risk Management for Medical Devices
REF: HL-EQP-14971
6
Subjects
500
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Practical Application of Risk Management 10 chapters · 50 marks
Understanding ISO 14971: Framework and Principles
Understanding ISO 14971: Principles of Risk Management in Medical Devices
Identifying Risks in Medical Device Development
Identifying and Analyzing Risks: Techniques and Tools
Risk Analysis Techniques for Medical Devices
Risk Evaluation and Acceptance Criteria in Medical Device Development
Risk Control Measures and Implementation
Implementing Risk Control Measures: Strategies and Best Practices
Continuous Risk Management: Monitoring and Review
Monitoring and Reviewing Risk Management Activities Over Product Lifecycle
2 Team Leadership and Management 5 chapters · 50 marks
Understanding Leadership Roles in ISO Risk Management for Medical Devices
Developing High-Performing Teams in a Risk Management Environment
Effective Communication Strategies for Risk Management Leadership
Navigating Challenges and Conflict in Medical Device Risk Management
Driving Continuous Improvement and Innovation in Risk Management Practices
3 Regulatory Affairs in Medical Devices 5 chapters · 50 marks
Understanding the Regulatory Landscape for Medical Devices in the UK
Introduction to ISO 14971 and Its Importance in Risk Management
Identifying and Analyzing Risks in Medical Device Development
Implementing Risk Control Measures and Evaluation of Residual Risks
Risk Management Documentation and Regulatory Compliance
4 Mitigation Strategies 5 chapters · 100 marks
Understanding Risk in Medical Devices: Key Concepts and Definitions
Identifying Risks: Techniques and Tools for Medical Devices
Risk Evaluation: Assessing Severity and Likelihood
Mitigation Strategies: Approaches and Best Practices
Monitoring and Reviewing Mitigation Effectiveness
5 ISO 14971 Framework 10 chapters · 100 marks
Understanding ISO 14971: Framework and Principles
Understanding ISO 14971: Core Principles and Objectives
Risk Management Process: Identification and Assessment
Risk Management Process: Identifying and Evaluating Risks
Risk Control Measures and Their Implementation
Risk Control Measures: Implementation and Assessment
Post-Market Surveillance and Risk Management Updates
Post-Market Surveillance and Risk Management Updates
Documentation and Quality Assurance in Risk Management
Leadership in Risk Management: Cultivating a Safety Culture
6 Risk Assessment Principles 5 chapters · 150 marks
Foundations of Risk Management in Medical Devices
Identifying Hazards and Risk Analysis Techniques
Risk Evaluation and Acceptance Criteria
Risk Control Strategies and Implementation
Monitoring and Review of Risk Management Processes
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

LAPT — London Academy of Professional Training
Master Certificate | Leadership | Level 6-7
Ref: HL-EQP-14971
lapt.org
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ISO 14971 — Risk Management for Medical Devices