The 2nd Medical Devices: Regulatory and Compliance Summit is dedicated to classification, conformity assessment and risk management in regulatory strategies to achieve compliance.
Topics
- Clinical affairs: data, evidence, equivalence and performance studies Achieving a smooth market access
- Overview of new guidelines, regulations and registration requirements Notified body feedback on EU MDR implementation
- Risk management changes
- UDI implementation: challenges and opportunities
- Practical insights from medical device manufacturers
- Engaging medical device manufacturers with cybersecurity requirements
- Classification of medical devices
- Updating technical documentation and labelling
- Post-marketing adverse event reporting
Who should Attend
Attendees involved or interested in:
- Controls & Robotics
- Medical Devices
- Device Design
- In Vitro Diagnostics
- Sterilization
- Medical Device Design
- Regulatory Affairs
- Product Quality
- Validation
- Research & Development
- Combination Products
- Design Controls
- CMC
- Medical Device Engineering
- Device Development & Manufacturing
- Compliance
- Quality Assurance/Control
- Supply Chain
- Risk Management
