Clinical Evaluation of Medical Devices

Course Outline:

To help you understand the broad scope of clinical investigation and the regulatory processes required with the alternative routes to demonstrate compliance.
The Masterclass will cover:

• EU MDD 93.42 to WU MDR 2017/745
• Who should perform the clinical evaluation
• Clinical evaluation for marketed devices PMS/PMCF, PSUR and SSCP
• The place of Clinical Evaluation within device life-cycle and tecnical documentation
• The equivalence assessment under MDR
• Clinical investigations under MDR
• Types of clinical studies
• ISO14155
• Clinical global strategy requirements - US FDA Specifics

When & Where?

When?
19 June 2020

Where?
At Your Desk

*Cost

Course fee for Members: £1,700 plus 20% VAT
Course fee for Students: £1,500 plus 20% VAT

• Delegates from the healthcare regulatory affairs profession who wish to develop their knowledge of the requirements for the clinical evaluation of medical devices
• Delegates from allied industries who wish to have a comprehensive understanding of the subject