Regulatory Considerations in Medical Device Prototyping
( 30 Modules )

Module #1
Introduction to Medical Device Regulations
Overview of the importance of regulatory considerations in medical device prototyping, regulatory bodies, and key regulations.

Module #2
Understanding FDA Regulations
In-depth review of FDA regulations, including 510(k) clearance, PMA, and breakthrough device designation.

Module #3
EU MDR and IVDR:Understanding European Regulations
Overview of the EUs Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), including classification, technical documentation, and CE marking.

Module #4
Other Global Regulations:Canada, Australia, and Asia
Review of regulations in Canada, Australia, Japan, China, and other key markets, including comparability to FDA and EU regulations.

Module #5
Risk Management and Hazard Analysis
Introduction to risk management principles, hazard analysis, and the role of risk assessment in medical device development.

Module #6
Design Controls and Design History File (DHF)
Explanation of design controls, design verification, and validation, and the importance of a Design History File (DHF) in regulatory compliance.

Module #7
Prototyping and Testing Best Practices
Guidelines for prototyping and testing, including verification and validation methods, and the role of testing in regulatory submissions.

Module #8
Material Selection and Biocompatibility
Discussion of material selection considerations, biocompatibility testing, and the importance of material characterization in medical device development.

Module #9
Sterilization and Packaging Considerations
Overview of sterilization methods, packaging requirements, and the importance of sterilization and packaging in medical device development.

Module #10
Labeling and Instructions for Use
Guidelines for labeling, instructions for use, and the importance of clear communication in medical device development.

Module #11
Clinical Evaluation and Clinical Trials
Introduction to clinical evaluation, clinical trials, and the role of clinical data in regulatory submissions.

Module #12
Quality Management System (QMS) and ISO 13485
Explanation of Quality Management System (QMS) principles, ISO 13485 requirements, and the importance of a QMS in regulatory compliance.

Module #13
Regulatory Submissions and Applications
Guidelines for preparing regulatory submissions, including 510(k) and PMA applications, and the importance of accurate and complete submissions.

Module #14
Regulatory Inspection and Audit Preparation
Tips for preparing for regulatory inspections and audits, including compliance with QMS and regulatory requirements.

Module #15
Post-Market Surveillance and Vigilance
Discussion of post-market surveillance and vigilance requirements, including adverse event reporting and corrective actions.

Module #16
Software and Cybersecurity Considerations
Introduction to software and cybersecurity considerations, including FDA guidance on software validation and cybersecurity requirements.

Module #17
Medical Device Classification and CE Marking
Explanation of medical device classification, CE marking requirements, and the role of Notified Bodies in the EU regulatory process.

Module #18
Regulatory Updates and Emerging Trends
Discussion of recent regulatory updates, emerging trends, and the importance of staying current with regulatory changes in medical device development.

Module #19
Collaboration and Communication with Regulators
Tips for effective collaboration and communication with regulators, including pre-submission meetings and regulatory feedback.

Module #20
Regulatory Considerations for Combination Products
Discussion of regulatory considerations for combination products, including drug-device and biologic-device combinations.

Module #21
Regulatory Considerations for 3D-Printed Devices
Introduction to regulatory considerations for 3D-printed medical devices, including FDA guidance and industry best practices.

Module #22
Regulatory Considerations for Wearable Devices
Discussion of regulatory considerations for wearable medical devices, including FDA guidance and industry best practices.

Module #23
Regulatory Considerations for Mobile Medical Apps
Introduction to regulatory considerations for mobile medical apps, including FDA guidance and industry best practices.

Module #24
Regulatory Considerations for Artificial Intelligence and Machine Learning
Discussion of regulatory considerations for artificial intelligence and machine learning in medical devices, including FDA guidance and industry best practices.

Module #25
Regulatory Considerations for Wireless and Connected Devices
Introduction to regulatory considerations for wireless and connected medical devices, including FDA guidance and industry best practices.

Module #26
Regulatory Considerations for Personalized Medicine
Discussion of regulatory considerations for personalized medicine, including FDA guidance and industry best practices.

Module #27
Regulatory Considerations for Gene Therapy and Gene Editing
Introduction to regulatory considerations for gene therapy and gene editing, including FDA guidance and industry best practices.

Module #28
Regulatory Considerations for Digital Health Technologies
Discussion of regulatory considerations for digital health technologies, including FDA guidance and industry best practices.

Module #29
Regulatory Considerations for Research and Development
Introduction to regulatory considerations for research and development, including IRB and ethics committee requirements.

Module #30
Course Wrap-Up & Conclusion
Planning next steps in Regulatory Considerations in Medical Device Prototyping career

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Regulatory Considerations in Medical Device Prototyping ( 30 Modules )

Regulatory Considerations in Medical Device Prototyping
( 30 Modules )