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Writing Clinical Investigation Plans for Medical Devices

Level:
Foundation
Area:
Medical Devices
Code:
MDF3
Duration:
03:00:00
Workshop profile:
This foundation workshop is for those who: · have never written a clinical investigation plan (CIP, synonym clinical study protocol) for medical devices · are coming from pharma, or · already have some experience in writing CIPs and want to gain a more profound understanding of this document. No attendance at a previous workshop is required. However, participants would benefit from having previously attended 'Basics of Writing for Medical Devices under the MEDDEV rev. 4 and new Medical Devices Regulations' (MDF1).
Objective:
The objective of this workshop is to teach participants how to write a CIP for medical devices. Those who have already some experience of writing CIPs will gain a deeper understanding of the background and points to consider. The workshop will focus on CIPs in Europe. Please bring your mobile phone, tablet or laptop with you as you will need them for exercises during the workshop.
Content:
Step-by-step, chapter-by-chapter participants will be taught how to write a CIP for medical devices. Not only will the different content requirements be explained, but also the strategic impact of specific sections. The workshop will also cover tips and tricks on how to gain specific information.