📄 ISO 10993 — Biological Evaluation of Medical Devices — Certification Brochure
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IS
LAPT
Master Certificate Level 6-7 Leadership ISO Health
ISO 10993 — Biological Evaluation of Medical Devices
REF: HL-EQP-10993
6
Subjects
500
Total Marks
65%
Pass Mark
Lifetime
Validity
Prerequisites

None

Awarding Body: LAPT — London Academy of Professional Training

Curriculum Overview
1 Leadership in Quality Assurance 5 chapters · 50 marks
Understanding ISO 10993 Standards and Their Importance
Biological Evaluation Frameworks and Risk Management
Leadership Skills in Quality Assurance Processes
Implementing Quality Assessment Strategies in Compliance
Future Trends in Quality Assurance and ISO 10993 Adaptation
2 Practical Application of ISO 10993 5 chapters · 50 marks
Understanding ISO 10993: Key Principles and Terminology
Regulatory Requirements and Risk Management in ISO 10993
Testing and Evaluation Strategies for Biological Safety
Practical Application of ISO 10993: Case Studies
Future Trends in Biological Evaluation of Medical Devices
3 Laboratory Testing and Analysis 5 chapters · 75 marks
Understanding ISO 10993 Standards and Their Importance
Types of Biological Testing: In Vitro and In Vivo Approaches
Risk Assessment Methodologies in Biological Evaluations
Interpreting Laboratory Results and Data Analysis Techniques
Regulatory Considerations and Reporting Requirements
4 Risk Management and Safety Assessment 5 chapters · 100 marks
Foundations of Risk Management in Medical Devices
ISO 14971: The Standard for Risk Management
Identifying Hazards and Assessing Risks
Risk Control Measures and Evaluation
Clinical Safety Assessment and Post-Market Surveillance
5 Biological Evaluation Principles 5 chapters · 125 marks
Fundamentals of Biological Evaluation in Medical Devices
ISO 10993 Standards Overview
Risk Assessment and Management in Biological Evaluation
Testing Methods and Evaluation Techniques for Biological Safety
Regulatory Compliance and Documentation for Biological Evaluation
6 Regulatory Framework for Medical Devices 5 chapters · 100 marks
Understanding Medical Device Regulatory Standards
Key Components of the ISO 10993 Standard
Risk Management in Medical Device Evaluation
Regulatory Pathways for Market Approval
Case Studies on ISO 10993 Implementation
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-10993
lapt.org
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ISO 10993 — Biological Evaluation of Medical Devices