ISO 22442 — Medical Devices Utilizing Animal Tissues — Certification Brochure

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London Academy of Professional Training
Certificate
ISO 22442 — Medical Devices Utilizing Animal Tissues
ISO Certification Programme
REF: HL-EQP-22442  •  ISO Health  •  Equipment
6Subjects 10Chapters 54Classes 430Total Marks 60%Pass Mark LifetimeValidity
At a Glance
ReferenceHL-EQP-22442
AwardCertificate
Assessment430 marks — 258 to pass (60%)
PrerequisitesNone
ValidityLifetime
Awarding BodyLAPT — London Academy of Professional Training
Curriculum
1 Ethical Considerations 0 chapters  45 marks
2 Future Trends in Medical Devices 0 chapters  45 marks
3 Quality Assurance Principles 0 chapters  85 marks
4 Regulatory Frameworks 5 chapters · 30 classes  105 marks
• 1 Understanding the Basics of ISO 22442 and Animal Tissue Regulations — 6 classes
› 1.1 Define ISO 22442 and Its Importance in Medical Devices
› 1.2 Explore the Regulatory Framework Surrounding Animal Tissues
› 1.3 Identify Key Terms and Definitions Related to ISO 22442
› 1.4 Analyze the Impact of Animal Tissue Regulations on Medical Device Design
› 1.5 Evaluate Compliance Strategies for ISO 22442 Implementation
› 1.6 Develop a Plan for Assessing Animal Tissue Sources in Medical Devices
• 2 Key Regulatory Bodies and International Standards — 6 classes
› 2.1 Identify Key Regulatory Bodies in Medical Device Standards
› 2.2 Explain the Role of ISO in Regulating Medical Devices
› 2.3 Analyze the Importance of Compliance with ISO 22442
› 2.4 Compare International Standards for Medical Devices
› 2.5 Assess the Impact of Regulatory Changes on Animal Tissue Use
› 2.6 Develop a Compliance Checklist for ISO 22442 Application
• 3 Risk Management and Compliance in Medical Device Development — 6 classes
› 3.1 Identify Key Risks in Medical Device Development
› 3.2 Assess The Impact of Animal Tissue Regulations
› 3.3 Implement Risk Management Strategies for Compliance
› 3.4 Analyze Case Studies of Risk Management Failures
› 3.5 Develop a Risk Management Plan for ISO 22442 Compliance
› 3.6 Monitor and Review Compliance in Medical Device Production
• 4 Ethical Considerations and Guidelines for Animal Tissue Use — 6 classes
› 4.1 Evaluate Ethical Principles Governing Animal Tissue Use
› 4.2 Examine Regulatory Frameworks for Animal Tissue in Medical Devices
› 4.3 Analyze Case Studies on Ethical Animal Tissue Usage
› 4.4 Identify Best Practices in Animal Tissue Sourcing
› 4.5 Develop Guidelines for Compliance with ISO 22442
› 4.6 Formulate a Strategy for Ethical Decision-Making in Animal Tissue Use
• 5 Implementing and Auditing ISO 22442 Compliance — 6 classes
› 5.1 Understand ISO 22442: Key Principles and Concepts
› 5.2 Identify Regulatory Requirements and Key Stakeholders
› 5.3 Develop Procedures for Complying with ISO 22442
› 5.4 Conduct Internal Audits for ISO 22442 Compliance
› 5.5 Analyze Audit Findings and Implement Continuous Improvement
› 5.6 Prepare for External Audits: Best Practices and Strategies
5 Risk Management Techniques 5 chapters · 24 classes  85 marks
• 1 Understanding Risk Management in Medical Devices — 6 classes
› 1.1 Define Key Terms in Risk Management for Medical Devices
› 1.2 Identify Common Risks Associated with Animal Tissue in Medical Devices
› 1.3 Analyze the Risk Management Process in Medical Device Development
› 1.4 Evaluate Risk Assessment Techniques for ISO 22442 Compliance
› 1.5 Explore Mitigation Strategies for Identified Risks in Medical Devices
› 1.6 Apply Risk Management Best Practices to Case Studies in Medical Device Scenarios
• 2 Identifying Risks in Animal Tissue Utilization — 6 classes
› 2.1 Analyze Regulatory Frameworks for Animal Tissue Use
› 2.2 Identify Types of Risks Associated with Animal Tissues
› 2.3 Assess Biological Hazards in Animal Tissue Utilization
› 2.4 Evaluate Processing and Storage Risks of Animal Tissues
› 2.5 Develop Risk Mitigation Strategies for Animal Tissue Handling
› 2.6 Implement a Risk Assessment Model for Animal Tissue Applications
• 3 Assessing Risks Using ISO 14971 Framework — 6 classes
› 3.1 Understand the ISO 14971 Framework for Risk Management
› 3.2 Identify Key Terms and Concepts Related to Risk in Medical Devices
› 3.3 Analyze Risk Factors Specific to Animal Tissue Medical Devices
› 3.4 Evaluate Risk Assessment Techniques Within the ISO 14971 Framework
› 3.5 Develop a Risk Management Plan for Medical Devices Utilizing Animal Tissues
› 3.6 Apply Risk Evaluation Outcomes to Enhance Device Safety and Compliance
• 4 Implementing Risk Control Measures — 6 classes
› 4.1 Identify Key Risks Associated with Animal Tissue in Medical Devices
› 4.2 Analyze Existing Risk Control Measures in Current Practices
› 4.3 Develop Effective Risk Control Strategies for Animal Tissue Usage
› 4.4 Evaluate the Effectiveness of Proposed Risk Control Measures
› 4.5 Implement Risk Control Measures and Monitor Compliance
› 4.6 Review and Update Risk Control Measures Based on Feedback and Findings
• 5 Monitoring and Reviewing Risk Management Processes
6 Strategic Management in ISO Practices 0 chapters  65 marks
LAPT — 85 Great Portland Street, W1W 7LT, London, United Kingdom
info@lapt.org  •  +44 7513 283044  •  lapt.org		 UKPRN 10067351  •  Company 4984798
Curriculum current at the date of issue.