Description
What You’ll Learn
- Understand the complete EU MDR regulatory framework and its practical implementation.
- Classify medical devices using Annex VIII with confidence.
- Develop an effective EU MDR regulatory strategy and select the correct conformity assessment route.
- Build compliant Annex II and Annex III Technical Documentation.
- Prepare a complete GSPR Compliance Matrix.
- Create an ISO 14971:2019 Risk Management File.
- Develop Clinical Evaluation Plans (CEP) and Clinical Evaluation Reports (CER).
- Prepare PMS Plans, PMCF Plans, and understand vigilance requirements.
- Create compliant labeling, Instructions for Use (IFU), and UDI assignments.
- Perform EUDAMED actor and device registration through guided demonstrations.
- Compile an audit-ready Technical Documentation package.
- Understand common Notified Body findings and prepare effective responses to deficiencies.
Why This Course Is Different
- Practical implementation rather than theoretical lectures.
- Real-world examples and industry best practices.
- Step-by-step creation of a complete Technical Documentation file.
- Live review sessions with instructor feedback.
- Mock Notified Body audit experience.
- Templates, examples, and implementation guidance that can be applied immediately in professional projects.
Who Should Enroll?
This course is ideal for:
- Regulatory Affairs Professionals
- Quality Assurance Professionals
- Medical Device Engineers
- Product Development Engineers
- Clinical Affairs Professionals
- Startups developing medical devices
- Medical device manufacturers seeking CE Marking
- Consultants supporting EU MDR compliance
- Professionals preparing for careers in Regulatory Affairs
- Anyone responsible for preparing or reviewing EU MDR Technical Documentation
Course Outcome
By the end of this course, you will have the knowledge, practical skills, and confidence to prepare submission-ready EU MDR Technical Documentation, support CE Marking projects, and successfully interact with Notified Bodies during conformity assessment and audits.
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