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WIZAPE
Apprentice Mode
10 Modules / ~100 pages
Wizard Mode
~25 Modules / ~400 pages

Clinical Applications and Testing of Biomedical Devices
( 25 Modules )

Module #1
Introduction to Biomedical Devices
Overview of biomedical devices, types, and applications
Module #2
Regulatory Framework for Biomedical Devices
FDA regulations, CE marking, and other international regulations
Module #3
Clinical Trials and Testing Methods
Types of clinical trials, testing methods, and study designs
Module #4
Biocompatibility Testing
ISO 10993 standards, cytotoxicity, and sensitization testing
Module #5
Sterilization and Cleaning Validation
Sterilization methods, cleaning validation, and packaging testing
Module #6
Mechanical and Performance Testing
Tensile strength, fatigue testing, and performance evaluation
Module #7
Electrical Safety Testing
Electrical safety standards, IEC 60601, and risk analysis
Module #8
Software Validation and Verification
Software development life cycle, verification, and validation
Module #9
Medical Imaging Devices
Clinical applications, image acquisition, and image processing
Module #10
Cardiovascular Devices
Stents, pacemakers, and implantable cardiac devices
Module #11
Neurological Devices
Neurostimulators, brain-computer interfaces, and neuroprosthetics
Module #12
Orthopedic and Musculoskeletal Devices
Joint replacements, implantable devices, and surgical instruments
Module #13
Ophthalmic Devices
Contact lenses, intraocular lenses, and ophthalmic surgical instruments
Module #14
Wound Care and Dressings
Wound healing, dressing types, and wound care devices
Module #15
In Vitro Diagnostic Devices
IVD devices, reagents, and calibration
Module #16
Point-of-Care Testing
POCT devices, blood glucose monitoring, and infectious disease testing
Module #17
Biomedical Sensors and Wearables
Sensor types, wearable devices, and health monitoring
Module #18
Clinical Practice and Device Integration
Device integration, clinical workflows, and healthcare IT
Module #19
Risk Management and Post-Market Surveillance
Risk management principles, post-market surveillance, and vigilance
Module #20
Design Control and Product Development
Design control principles, product development, and failure mode analysis
Module #21
Manufacturing and Quality Control
Manufacturing processes, quality control, and supply chain management
Module #22
Labeling and User Interface Design
Labeling requirements, user interface design, and human factors engineering
Module #23
Clinical Evaluation and Clinical Investigation
Clinical evaluation reports, clinical investigation plans, and study protocols
Module #24
Medical Device Standards and Guidelines
International standards, guidelines, and best practices
Module #25
Course Wrap-Up & Conclusion
Planning next steps in Clinical Applications and Testing of Biomedical Devices career


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