IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 22442 — Medical Devices Utilizing Animal Tissues
REF: HL-EQP-22442
6
Subjects
500
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Future Trends in Medical Devices 0 chapters · 50 marks
2 Strategic Management in ISO Practices 0 chapters · 75 marks
3 Ethical Considerations 0 chapters · 50 marks
4 Quality Assurance Principles 0 chapters · 100 marks
5 Risk Management Techniques 5 chapters · 100 marks
Understanding Risk Management in Medical Devices
Identifying Risks in Animal Tissue Utilization
Assessing Risks Using ISO 14971 Framework
Implementing Risk Control Measures
Monitoring and Reviewing Risk Management Processes
6 Regulatory Frameworks 5 chapters · 125 marks
Understanding the Basics of ISO 22442 and Animal Tissue Regulations
Key Regulatory Bodies and International Standards
Risk Management and Compliance in Medical Device Development
Ethical Considerations and Guidelines for Animal Tissue Use
Implementing and Auditing ISO 22442 Compliance
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

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ISO 22442 — Medical Devices Utilizing Animal Tissues