Testing and Validation of Medical Devices
( 25 Modules )

Module #1
Introduction to Medical Device Testing and Validation
Overview of the importance of testing and validation in medical device development, regulatory requirements, and industry standards

Module #2
Regulatory Framework for Medical Devices
Review of key regulations, such as FDAs 510(k) and PMA, EUs MDR and IVDR, and ISO 13485

Module #3
Types of Medical Device Testing
Overview of different testing types, including verification, validation, and design validation

Module #4
Test Planning and Strategy
Creating a test plan, identifying testing requirements, and developing a testing strategy

Module #5
Risk Management in Medical Device Testing
Applying risk management principles to testing, including risk analysis and mitigation

Module #6
Design Verification Testing
Design verification testing methods, including inspection, testing, and analysis

Module #7
Design Validation Testing
Design validation testing methods, including clinical evaluation, usability testing, and performance testing

Module #8
Biocompatibility Testing
Biocompatibility testing methods, including cytotoxicity, sensitization, and irritation testing

Module #9
Electrical Safety Testing
Electrical safety testing methods, including IEC 60601-1 and UL 60601-1

Module #10
Performance Testing
Performance testing methods, including functional testing and durability testing

Module #11
Sterilization and Cleaning Validation
Sterilization and cleaning validation methods, including steam sterilization and cleaning validation

Module #12
Packaging and Labeling Validation
Packaging and labeling validation methods, including packaging integrity and labeling compliance

Module #13
Clinical Evaluation and Clinical Trials
Clinical evaluation and clinical trials, including study design, ethics, and regulatory submissions

Module #14
Usability and Human Factors Testing
Usability and human factors testing methods, including user research and usability testing

Module #15
Software Validation
Software validation methods, including verification, validation, and testing

Module #16
Cybersecurity Testing
Cybersecurity testing methods, including risk assessment, vulnerability testing, and penetration testing

Module #17
Test Method Validation
Test method validation principles, including accuracy, precision, and linearity

Module #18
Test Report Writing and Review
Best practices for writing and reviewing test reports, including data analysis and interpretation

Module #19
Test Data Management and Documentation
Test data management and documentation principles, including data archiving and retrieval

Module #20
FDA and CE Marking Regulations
FDAs 510(k) and PMA regulations, and EUs CE marking regulations for medical devices

Module #21
International Standards for Medical Devices
Overview of international standards, including ISO 13485, ISO 14971, and IEC 60601

Module #22
Auditing and Quality Management
Auditing and quality management principles, including auditing techniques and quality management systems

Module #23
Risk-Based Testing and Validation
Risk-based testing and validation methods, including risk assessment and mitigation strategies

Module #24
Post-Market Surveillance and Vigilance
Post-market surveillance and vigilance principles, including adverse event reporting and recall management

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Testing and Validation of Medical Devices career

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Testing and Validation of Medical Devices ( 25 Modules )

Testing and Validation of Medical Devices
( 25 Modules )