Medical Devices
Clinical Trials
Clinical Investigations and Evaluation for Medical Devices
Price available after dates are announced
TRAINING TIMES
- TBDVienna
- TBDLondon
- TBDNew York
- TBDLos Angeles
LEARNING OBJECTIVES
Gain an update on the regulatory requirements
Gain an update on the regulatory requirements
Understand different study types
Understand different study types
Determine whether or not a clinical investigation is required
Determine whether or not a clinical investigation is required
Understand sufficient quality & level of evidence requirements
Understand sufficient quality & level of evidence requirements
Determine technical, biological, and clinical evidence for a development plan
Determine technical, biological, and clinical evidence for a development plan
Understand ‘state of the art’ in medicine
Understand ‘state of the art’ in medicine
Assess the usability of medical devices registries
Assess the usability of medical devices registries
KEY TOPICS
Regulatory requirements & pathways (EU, US and UK) Clinical evidence – clinical development plan, clinical benefits Clinical investigations – process, risk, parameters & design
Medical device registries 
