Event Description

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
Applicant Requirements
- 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