1. Introduction to Medical Devices and IVDs
Overview of Medical Devices and IVDs
Classification of Medical Devices and IVDs
Regulatory Definitions and Examples
Importance of Compliance and Safety
2. Regulatory Landscape
Overview of Global Regulatory Authorities
FDA (USA)
EMA (Europe)
TGA (Australia)
WHO
Standards and Guidelines (ISO 20416, ISO 14971, etc.)
Regulatory Differences Between Devices and IVDs
3. Design and Development
Design Control Process
User Needs and Design Inputs
Risk Management (ISO 14971)
Human Factors Engineering
Prototyping and Design Validation
4. Quality Management Systems (QMS)
Introduction to ISO 13485, ISO 9001, ISO 17025, ISO 15189
Document and Record Management
Supplier and Vendor Management
Audits and Inspections
5. Clinical Evaluation and Performance Studies
Clinical Investigation Planning
Preclinical and Clinical Study Requirements
Post-Market Clinical/performance Follow-Up (PMCF-PMPF)
Performance Evaluation of IVDs
6. Manufacturing and Supply Chain
Good Manufacturing Practices (GMP)
Process Validation
Material Traceability
Packaging and Labeling Requirements
7. Regulatory Submissions and Market Approvals
Premarket Notification (510(k)), Premarket Approval (PMA) - FDA
CE Marking and European MDR/IVDR
Declarations of Conformity
UDI (Unique Device Identification)
8. Post-Market Surveillance
Complaint Handling
Adverse Event Reporting
CAPA (Corrective and Preventive Actions)
Product Recalls and Market Withdrawals
9. Risk Management and Safety
Risk Assessment Frameworks
Failure Mode and Effects Analysis (FMEA)
Mitigation Strategies
Cybersecurity in Medical Devices
10. Digital Transformation in Medical Devices and IVDs
Software as a Medical Device (SaMD)
Artificial Intelligence and Machine Learning Applications
Digital Health Ecosystems
Emerging Technologies in IVD
11. Practical Workshops and Case Studies
Hands-on Training on QMS Documentation
Mock Regulatory Submissions
Analyzing Real-Life Case Studies of Product Launches
Crisis Management Scenarios (Recalls, Regulatory Audits)
12. Ethics, Compliance, and Best Practices
Patient Data Protection (HIPAA, GDPR)
Ethical Marketing and Distribution
Continuous Professional Development
Industry Trends and Innovations
13. Certification and Continuing Education
Certification Exams
Access to Continuing Education Resources
Pathways for Advanced Specializations
14. Resources and Tools
Templates (QMS, Risk Management, Regulatory Submission)
Checklists and Guidelines
Glossary of Key Terms
Recommended Reading and Online Resources
Contact us if you need support in any of these topics!
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