Regulatory Challenges in Medical Technology Entrepreneurship
( 24 Modules )

Module #1
Introduction to Regulatory Challenges
Overview of the importance of regulatory compliance in medical technology entrepreneurship

Module #2
Understanding FDA Regulations
Introduction to the FDA and its role in regulating medical devices and technologies

Module #3
Medical Device Classification
Understanding FDAs classification system for medical devices and its implications

Module #4
510(k) vs. PMA:Navigating the FDA Approval Process
Comparison of the 510(k) and PMA approval processes and when to use each

Module #5
Human Factors Engineering and Usability
Designing medical devices with user needs and safety in mind

Module #6
Design Controls and Design History File
Best practices for design controls and maintaining a design history file

Module #7
Risk Management and Hazard Analysis
Identifying and mitigating risks associated with medical devices

Module #8
Clinical Trials and Clinical Evaluation
Conducting clinical trials and evaluating clinical data for medical devices

Module #9
Labeling and Instructions for Use
Creating accurate and compliant labeling and instructions for medical devices

Module #10
Post-Market Surveillance and Vigilance
Monitoring and reporting on medical device performance after market release

Module #11
International Regulatory Considerations
Overview of regulatory requirements for medical devices in major markets outside the US

Module #12
CE Marking and the European Unions Medical Device Regulation
Understanding the CE marking process and EU MDR requirements

Module #13
Health Canada and Canadian Regulatory Requirements
Overview of Health Canadas regulatory requirements for medical devices

Module #14
Australian Therapeutic Goods Administration (TGA) and Regulatory Requirements
Understanding the TGAs regulatory requirements for medical devices in Australia

Module #15
Quality Management Systems and ISO 13485
Implementing a quality management system that meets international standards

Module #16
Good Manufacturing Practices (GMP) and Manufacturing Controls
Following GMP principles to ensure quality and compliance in manufacturing

Module #17
Sterilization and Packaging Validation
Validating sterilization and packaging processes for medical devices

Module #18
Software as a Medical Device (SaMD) and Digital Health Regulations
Understanding regulatory requirements for software-based medical devices and digital health products

Module #19
Cybersecurity and Medical Devices
Protecting medical devices from cybersecurity threats and vulnerabilities

Module #20
Supply Chain Risk Management and Vendor Management
Mitigating risks associated with medical device supply chains and vendor relationships

Module #21
Regulatory Strategies for Startup Companies
Navigating regulatory challenges as a startup company in medical technology

Module #22
Regulatory Affairs:Roles and Responsibilities
Understanding the roles and responsibilities of regulatory affairs professionals in medical technology companies

Module #23
Stay Current:Keeping Up with Regulatory Changes and Updates
Staying informed about changes to regulatory requirements and guidelines

Module #24
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Challenges in Medical Technology Entrepreneurship career

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Regulatory Challenges in Medical Technology Entrepreneurship ( 24 Modules )

Regulatory Challenges in Medical Technology Entrepreneurship
( 24 Modules )