Clinical Evaluation
Course length: 1 Day
Facts
Each day 08:30 – 16:30 (8.30 a.m. – 4.30 p.m.)
Background:
Creating and reviewing the Clinical Evaluation of a Medical Device is a very important and critical step for the development and registration of a new Medical Device. Regulators around the world are increasing expectations for clinical evaluation of medical devices for all devices with tougher requirements for higher risk devices and especially implantables. This course will explore the key points related to Clinical Evaluation and will give guidance into this key process.
Content:
• Regulatory Requirements and Guidelines• Literature Searching• Appraising and Selecting Clinical Data• Analyzing Clinical Data• Writing CER – Technical Components• Drawing Conclusions – Team/Medical Review
Who Will Benefit:
• Medical Device R&D Engineers and Scientists• Clinical and Regulatory Affairs Professionals