Green Biotec UG Bremen Germany
Regulatory Affairs for Medical Devices
| Regulatory Affairs for Medical Devices | |
|---|---|
| Course Description | This two-month training program provides a comprehensive understanding of the regulatory landscape for medical devices. Students will explore the lifecycle of a medical device, from conceptualization to commercialization, focusing on regulatory compliance, market strategies, and quality management systems. Designed for individuals pursuing careers in medical devices, quality assurance, bioengineering, or marketing, this course equips learners with practical skills to navigate regulatory frameworks and industry standards effectively. |
| Recommended Books | 1. Medical Device Regulations: Global Overview and Guiding Principles by WHO 2. The Medical Device R&D Handbook by Theodore R. Kucklick 3. ISO 13485:2016 and FDA QSR Regulations Explained by Elaine J. Duncan |
| Course Learning Outcomes | After completing this course, students will: 1. Understand the role of regulatory affairs across the lifecycle of medical devices. 2. Gain knowledge of global and EU-specific regulatory frameworks and standards. 3. Develop skills to manage risks, conduct clinical evaluations, and maintain compliance. 4. Explore strategies for market analysis and post-market surveillance. |
| Assessment System | Quizzes: 10-15% Assignments: 5-10% Midterms: 30-40% End Semester Exam: 40-50% |
| Lecture Plan | ||
|---|---|---|
| S.No. | Description | Quizzes/Assignment |
| 1 | Introduction to Medical Devices and Key Trends in the Industry | Quiz 1 |
| 2 | History and Evolution of Medical Device Regulatory Affairs | |
| 3 | Market Challenges and Strategic Analysis | Assignment 1 |
| 4 | Medical Device Classification and ISO Standards | |
| 5 | Role of Quality Management Systems in Regulatory Compliance | Quiz 2 |
| 6 | Risk Management in Medical Devices | |
| 7 | IEC International Standards and Conformity Assessment | Assignment 2 |
| 8 | European Union Medical Device Regulatory System | Quiz 3 |
| 9 | Clinical Evaluations and Certification Processes | |
| 10 | Post-Market Surveillance and Transition from MDD to MDR | Assignment 3 |
| 11 | State and Federal Site Inspections | |
| 12 | Universal Device Identification and International Marketing | Quiz 4 |
| 13 | Follow-Ups and Risk Reviews in Regulatory Affairs | |
| 14 | Case Studies: Best Practices in Medical Device Compliance | Assignment 4 |
| 15 | Emerging Trends in Medical Device Regulations | |
