Preamble
Clinical evidence plays an important role in the conformity assessment procedure for medical devices. No further approval will be possible in Europe and ASEAN including Thailand without sufficient clinical data to prove the safety, performance and benefit of a medical device. This training will provide you with the basic requirements of the European laws and guidelines for clinical evaluation and their implementation in the context of the conformity assessment procedure for medical devices, covering the entire product life cycle.
The collection of clinical data is a critical aspect in the conformity assessment process of medical devices, and serves to substantiate a manufacturer’s claim regarding the safety, performance and benefit/risk ratio of a given device. Clinical data is generally understood as evidence on the safety and performance of a medical device based on actual usage of the device, and is typically derived from pre-clinical or clinical investigations, scientific literature and/or clinical experiences with equivalent devices.
This one-day course provides an overview of the clinical evaluation process for medical devices according to the Medical Device Regulation (MDR 2017/745), MEDDEV 2.7/1 Revision 4 and applicable MDCG guidance documents.
Who Should Attend
Managers, Executives, Supervisors of various departments: Regulatory Affairs, Quality Assurance, Research & Development, Regulatory Authorities should attend this seminar.
How will you benefit?
• Acquire know-how for the targeted identification and provision of required clinical data for medical devices.
• Be able to successfully clinically evaluate your medical device.
• Be able to implement regulatory requirements and comply with official guidelines regarding the clinical evaluation of medical devices.
• Be able to Determine when clinical evaluation is undertaken and the frequency of updates
• Interpret and communicate the key requirements and expectations of medical device clinical evaluation to your organization