The EU Medical Device Regulation (MDR) - Implementation Course
EU Medical Device Regulation (MDR) – 3-Day Implementation Training This 3-day course provides a comprehensive understanding of EU MDR 2017/745, including classification rules, technical documentation, clinical evaluation, post-market surveillance, and CE marking requirements. Participants will gain practical insights into MDR compliance, risk management (ISO 14971), and QMS integration (ISO 13485) through expert-led sessions, case studies, and interactive exercises. 📅 Duration: 3 Days | 📜 Certificate of Completion | 📍 In-Person / Online
نظرة عامة على الدورة
ما ستتعلمه
By the end of this course, participants will:
✅ Understand the structure, scope, and key requirements of EU MDR 2017/745
✅ Learn the classification rules and conformity assessment pathways
✅ Implement technical documentation and clinical evaluation requirements
✅ Ensure compliance with post-market surveillance (PMS) and vigilance
✅ Integrate MDR requirements with ISO 13485 Quality Management Systems
✅ Gain insights into Notified Body interactions and CE marking processes
لمن هذه الدورة
✅ Gain practical knowledge for EU MDR compliance
✅ Stay ahead of regulatory changes & expectations
✅ Ensure smooth transition from MDD to MDR
✅ Learn from industry experts with hands-on experience
📅 Duration: 3 Days
📍 Delivery Mode: In-Person / Online (Live Instructor-Led)
📜 Certification: Certificate of Completion Provided
عن هذه الدورة
This 3-day training course provides a comprehensive understanding of the EU Medical Device Regulation (MDR) 2017/745and its impact on medical device manufacturers, suppliers, and regulatory professionals. The course covers the key regulatory requirements, compliance strategies, and practical implementation approaches to
This course is ideal for professionals involved in medical device compliance, including:
- Regulatory Affairs & Compliance Officers
- Quality Assurance & Quality Control Professionals
- Medical Device Manufacturers & Suppliers
- Product Development & R&D Teams
- Auditors & Consultants
ensure a smooth transition and adherence to EU MDR requirements.