An Introduction to the Medical Device Regulation is a seminar dedicated to a detailed introduction to the European medical device legislation.
Topics
- What a Competent Authority expects
- The role of a Notified Body
- Comply with Manufacturing Responsibilities
- Conformity Assessment Procedures, Classification, Medical Device legislation
- Clinical Evaluations
- The requirements for Quality Systems
Who should Attend
Attendees involved or interested in:
- Pharmacovigilance
- Regulatory Affairs
- Technical Support
- Quality Assurance