This course has been designed specifically for those who are involved in gathering clinical evidence required for medical devices and in-vitro diagnostic products. Clinical data is required for all medical devices and the emphasis on high quality, appropriate clinical evidence has grown substantially in the last few years.
Clinical evidence is key to bringing a device to market and is a very important aspect of post market evidence gathering to meet the legislation. The collection of clinical data to demonstrate safety and performance of a device is pivotal to CE marking a medical device. The collection of post market data is a key aspect of continued safety and performance considerations once the device is on the market.
This course will cover the full range of activities that should be applied during the collection of clinical evidence for both pre and post market studies. It will provide delegates with information on the European regulations for gathering clinical evidence and conducting medical device studies and help them to run studies in Europe and other countries.
Delegates should benefit from the advice and tips on the practicalities of conducting studies within Europe as well as the types of clinical data to collect in order to be compliant.
Programme Day One
- Welcome, Introductions and Course Objectives
- The Regulatory Aspects of Gathering Clinical Evidence for Devices
- Conducting a Pre-Market Clinical Evaluation/Literature Review
- Conducting a Pre-Market (Regulatory) Clinical Investigation
- Documentation for Pre-Market (Regulatory) Clinical Investigations
- How to obtain the necessary approvals for Pre-Market Studies
- The Differences between Drugs and Devices
Programme Day Two
- Study Management and monitoring of regulatory clinical investigation
- How to write a Final Study Report for a regulatory Clinical Investigation Pre Market Study
- Post Market Clinical Follow Up Studies
- What about In-Vitro Diagnostic Devices
- Current key issues affecting clinical evidence for medical devices
For more information about this conference visit http://www.researchandmarkets.com/research/9w78nw/medical_device