Februar 27, 2019 - Februar 27, 2019
Date: February 27, 2019
Time: 4:00 - 8:00 PM (check-in time 3:30 PM)
Location: Waltham Woods Corporate Center, Boston, MA
Jasmin Hunter, Clinical & Regulatory Affairs Consultant at Qserve Group, is invited as speaker at the ASQ Biomedical Division New England Discussion Group on Clinical Evaluation Reports Compliance with MEDDEV 2.7.1.
What will you learn:
1. Key aspects of MEDEV 2.7.1, Rev. 4 and MDR Requirements
2. How to comply with the Regulations
What to include in a Clinical Evaluation Plan
What to include in a Clinical Evaluation Report
How to demonstrate "State of the Art"
How to demonstrate sufficient clinical evidence
3. Real world examples/challenges
Definition of equivalence / What if you are not equivalent?
How to incorporate PMS data / other creative solutions
Risk/Benefit Assessment - Importance of Medical Perspective
When a PMCF / Clinical Study is needed
For the full program details and registration, please visit this event webpage.