ISO 22442 — Medical Devices Utilizing Animal Tissues

LAPT

London Academy of Professional Training

Master Certificate Level 6-7 Leadership ISO Health

REF: HL-EQP-22442

Subjects

500

Total Marks

65%

Pass Mark

Lifetime

Validity

Who Is It For

This certification is designed for professionals in leadership roles within the medical device industry, particularly those overseeing teams or projects involving animal tissues. Candidates are expected to have significant industry experience and are seeking to enhance their expertise in regulatory compliance and risk management.

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 · 24 classes · 100 marks

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

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

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

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

Monitoring and Reviewing Risk Management Processes

6 Regulatory Frameworks 5 chapters · 30 classes · 125 marks

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

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

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

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

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

Assessment Breakdown

50%

Theory

35%

Practical

15%

Project

Passing Mark: 325 / 500 (65%)

Methods: Written Examination, Practical Assignment, Portfolio Assessment

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

📩 Send Enquiry