MATERIOVIGILANCE

This course covers the essential principles of medical device vigilance, clinical evaluation, post-market surveillance (PMS), and compliance with global regulatory frameworks such as Medical Device Regulation (MDR), Medical Device Directive (MDD), MedDev Rev 4, and In Vitro Diagnostic Regulation (IVDR). Participants will gain practical knowledge of medical device documentation, safety reporting, and literature appraisal, equipping them with the skills necessary for careers in medical device regulatory affairs, safety monitoring, and clinical evaluation writing.

Key Learning Modules:

1. Introduction to Materiovigilance & Medical Devices

✔ Overview of Medical Devices & In Vitro Diagnostics (IVDs)

✔ Differences between Medical Devices & Drugs in terms of regulation, safety reporting, and documentation

✔ Career Opportunities in Medical Device Regulatory Affairs and Safety

2. Medical Device Regulations & Compliance

✔ Introduction to MedDev Rev 4 Guidelines

✔ Medical Device Directive (MDD) vs. Medical Device Regulation (MDR)

✔ Understanding Regulatory Requirements for Medical Device Approval

✔ Overview of In Vitro Diagnostic Regulation (IVDR) 3. Clinical Evaluation Report (CER) & Medical Device Documentation

✔ Overview of Clinical Evaluation Reports (CERs) – Structure & Importance

✔ Claiming Equivalency for Medical Devices

✔ State of the Art (SOTA) in Medical Device Evaluations

✔ Literature Appraisal & Writing Literature Summaries 4. Risk-Benefit Analysis & Post-Market Surveillance (PMS)

✔ How to Conduct a Risk-Benefit Analysis for Medical Devices

✔ Post-Market Surveillance (PMS) & Post-Market Clinical Follow-up (PMCF) – Data Collection & Reporting 5. Hands-On Training & Case Studies

✔ Writing & Reviewing Medical Device Regulatory Documents

✔ Case studies on Medical Device Safety Monitoring & Compliance Who Should Attend?

✅ Regulatory Affairs & Materiovigilance Professionals

✅ Pharmaceutical & Medical Device Industry Professionals

✅ Medical Writers, Clinical Evaluators & Compliance Experts

✅ Life Sciences, Pharmacy, and Healthcare Graduates

✅ Anyone Seeking a Career in Medical Device Regulations & Safety Monitoring