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Training for medical professionals

PROFESSIONAL DEVELOPMENT



FOR MEDICAL DEVICES AND IVDs

Welcome to IVDEXEL Training Academy
At IVDEXEL, we are committed to equipping professionals in the medical device and in vitro diagnostic (IVD) industries with the knowledge and skills necessary to navigate the complex world of regulatory compliance, quality management, and product development.

Our training programs are meticulously designed to address the unique challenges faced by manufacturers, sponsors, and distributors. Whether you are new to the industry or a seasoned professional, our courses offer valuable insights, practical tools, and the latest industry best practices to help you ensure safety, efficacy, and market success for your products.

What We Offer:

  • Comprehensive Course Catalog: Covering everything from regulatory frameworks and quality systems to risk management and digital transformation in medical devices and IVDs.

  • Expert-Led Training: Learn from industry leaders with real-world experience in regulatory submissions, clinical evaluations, and quality audits.

  • Practical Applications: Interactive workshops, case studies, and templates designed to enhance hands-on learning and immediate application.

  • Customized Learning Paths: Tailored solutions to meet the specific needs of individuals and organizations.

Join us to enhance your expertise, stay ahead of regulatory changes, and contribute to a safer, more innovative healthcare landscape. Explore our course offerings today and take your knowledge to the next level!

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Training Course Directory:

1. Introduction to Medical Devices and IVDs

  • Overview of Medical Devices and IVDs

  • Classification of Medical Devices for different markets

  • Regulatory Definitions and Examples

  • Importance of Compliance and Safety

2. Regulatory Landscape

  • Overview of Global Regulatory Authorities

    • FDA (USA)

    • EMA (Europe)

    • TGA

    • MHRA (UK)

    • WHO

  • Standards and Guidelines (ISO 13485, 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)

  • Prototyping and Design Validation

4. Quality Management Systems (QMS)

  • Introduction to standards (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

  • 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

  • Post-Market Clinical/Performance Follow-Up (PMCF/PMPF). 

9. Risk Management and Safety

  • Risk Assessment Frameworks

  • Failure Mode and Effects Analysis (FMEA)

  • Mitigation Strategies

10. Digital Transformation in Medical Devices and IVDs

  • Software as a Medical Device (SaMD)

  • Artificial Intelligence and Machine Learning Applications

  • Cyber security for Medical devices

  • Emerging Technologies

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)

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