09:00 - 10:00
This is a crash course in how to conduct a Clinical Evaluation according to Medical Device Regulation (MDR) and MEDDEV 2.7/1 rev 4 2016.
Norway Health Tech Academy and our partner Qmed Academy will be presenting a Clinical Evaluation and Assessment Training Series. This first webinar will give an overview of Clinical Evaluation and what you can expect from the full series of courses. During this webinar participants will learn about the follow objectives:
• Regulatory background
• When to conduct a clinical evaluation
• Who should perform the clinical evaluation
• The demonstration of equivalence
• The clinical evaluation stages
• How to write up a Clinical Evaluation Report according to MDR
This webinar is for Medical Device specialist working within Regulatory Affairs, Clinical Affairs or similar that are about to write up a Clinical Evaluation Report for the first time. Or experienced Medical Device Specialists that needs a brush up on the new Medical Device Regulation and the requirements specific to the Clinical Evaluation process.
This webinar will be complementary