Introduction to Clinical Evaluation for Medical Devices
PrintA NSF-DBA Medical Devices Course designed and prepared for the Medical Device industry
£600.00 excl. VAT
About this course
The clinical evaluation process is an essential aspect of the CE marking process which must be conducted for all medical devices from Class I through to Class III.
This course is designed to provide an introduction to the clinical evaluation process and help you understand the basic concepts involved in conducting a clinical evaluation.
There are many different professionals involved either directly or indirectly in the clinical evaluation process at different levels. This introduction will help you to understand the whole of the process including how you can utilise the information gathered.
We will provide you with the knowledge and practical interpretation you need to understand the clinical evaluation process so that you can comfortably talk about it to others and also understand where it fits in the development and marketing of medical devices.
What You Will Learn
At the end of this one-day introductory course you will be familiar with all the terminology related to clinical evaluations. You will understand the basic process, why and how a clinical evaluation is conducted. You will know which regulations and which guidance documents apply to the clinical evaluation process. You will have sufficient insight into the process to talk confidently about it and explain what it involves to others. You will also understand clearly where clinical evaluations fit into your own role and the role of others involved in device development and marketing.
Who Should Attend
This is an introductory course which provides an overview of what a clinical evaluation is for those who have had no experience of clinical evaluations and need to understand the basic process. It is applicable to anyone who is involved either directly or indirectly in the clinical evaluation process. It will be particularly useful to those new to clinical evaluations who are working at any level in research and development, clinical, regulatory, quality or marketing of medical devices.
