Biomedical Device Development
( 25 Modules )

Module #1
Introduction to Biomedical Device Development
Overview of the biomedical device industry, importance of device development, and course objectives

Module #2
Regulatory Framework for Biomedical Devices
Understanding FDA regulations, classification, and compliance requirements for biomedical devices

Module #3
Design Controls for Biomedical Devices
Design control principles, design inputs, design verification, and design validation

Module #4
Human Factors Engineering in Biomedical Devices
Understanding user needs, user-centered design, and risk analysis for biomedical devices

Module #5
Materials Science for Biomedical Devices
Overview of biomaterials, material selection, and material testing for biomedical devices

Module #6
Mechanical Engineering Principles for Biomedical Devices
Mechanical design principles, mechanical testing, and mechanical failure analysis for biomedical devices

Module #7
Electronics and Electrical Engineering for Biomedical Devices
Electrical design principles, electrical safety, and electromagnetic compatibility for biomedical devices

Module #8
Software Engineering for Biomedical Devices
Software design principles, software testing, and software validation for biomedical devices

Module #9
Biomaterials and Biocompatibility
Biocompatibility testing, biomaterials for implantable devices, and surface modification techniques

Module #10
Sterilization and Packaging for Biomedical Devices
Sterilization methods, packaging materials, and packaging design for biomedical devices

Module #11
Quality Management Systems for Biomedical Devices
ISO 13485, quality management principles, and quality system implementation for biomedical devices

Module #12
Risk Management for Biomedical Devices
Risk management principles, risk analysis, and risk mitigation strategies for biomedical devices

Module #13
Clinical Trials for Biomedical Devices
Clinical trial design, clinical trial conduct, and clinical trial data analysis for biomedical devices

Module #14
Medical Device Classification and Nomenclature
Global Medical Device Nomenclature, device classification, and device labeling regulations

Module #15
Patent and Intellectual Property Law for Biomedical Devices
Patent law, patent application process, and intellectual property protection for biomedical devices

Module #16
Biomedical Device Manufacturing and Production
Manufacturing processes, production planning, and supply chain management for biomedical devices

Module #17
Post-Market Surveillance and Vigilance
Post-market surveillance, adverse event reporting, and device recalls for biomedical devices

Module #18
Medical Device Standards and Regulations Worldwide
Overview of international regulations, CE marking, and ISO standards for biomedical devices

Module #19
Biomedical Device Safety and Performance
Device safety, performance testing, and device failure analysis for biomedical devices

Module #20
Human Clinical Trials and Clinical Research
Clinical research methods, clinical trial ethics, and good clinical practice for biomedical devices

Module #21
Biomedical Device Entrepreneurship and Commercialization
Entrepreneurship principles, business planning, and go-to-market strategies for biomedical devices

Module #22
FDA 510(k) and PMA Submissions
FDA 510(k) and PMA submission processes, device clearance, and device approval

Module #23
Biomedical Device Labeling and Instructions for Use
Device labeling, instructions for use, and user manuals for biomedical devices

Module #24
Medical Device Cybersecurity
Cybersecurity risks, cybersecurity testing, and cybersecurity regulations for biomedical devices

Module #25
Course Wrap-Up & Conclusion
Planning next steps in Biomedical Device Development career

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Biomedical Device Development ( 25 Modules )

Biomedical Device Development
( 25 Modules )