M3 - CE & Global Clinical Requirements - Medical Devices Clinical Evaluation - Step by Step (QP)
PrintPart of our Medical Devices QP Training Module 3
£1470.00 excl VAT
About this course
Learn how to undertake a critical review of scientific and clinical data in order to present a robust clinical evaluation of your device technology’s clinical performance. This course will enable you to understand the disciplined approach required to meet the requirements for clinical evaluation defined within 93/42/EEC Annex X and identify when clinical data is sufficient and not sufficient to support your medical device.
Who Should Attend
Development, regulatory and clinical personnel involved in the formulation of clinical investigations, evaluations and post market clinical follow-up of medical devices. The medical devices requirements are placing a major emphasis upon clinical data requirements for devices, therefore programme managers, marketing and senior managers will also benefit from this module in that they will be able to understand the clinical requirements necessary for their devices and plan an appropriate commercialization strategy.

