An NSF International Company Clinical Evaluation for Medical Devices - Practitioner Course
PrintA NSF-DBA Medical Devices Course designed and prepared for the Medical Device industry
£1200.00 excl. VAT
About this course
This course is designed to provide you with the expert skills needed to produce a high quality clinical evaluation report. It is very much a practitioner course that takes you through the process in depth and gives you the skills to produce a substantial clinical evaluation report that clearly determines whether or not a clinical investigation is needed or whether sufficient data exists.
The course provides you with excellent template documents which can be used throughout the clinical evaluation process to ensure appropriate data is chosen and reviewed.
We will provide you with the skills and practical knowledge enabling you to plan and write clinical evaluations to an exceptionally high standard.
What You Will Learn
At the end of this two-day practitioner course you should be able to produce high quality clinical evaluation reports. You will know how to conduct a literature review and how to structure and build all the necessary documents which form part of the clinical evaluation process. You will have sufficient practice over the two days to become skilled at conducting clinical evaluations. At the end of the course you should clearly understand the following:
- Which regulatory and guidance documents to use and how to use/interpret them
- How to write a clinical evaluation plan including objectives, methodology and literature searching processes
- How to conduct a systematic literature review including identifying sources, selecting and appraising documents
- Where risk management fits into the process
- How to write a clinical evaluation report including format, contents and layout
Who Should Attend
This course is intended for those who have some familiarity with the basic concepts of a clinical evaluation and are familiar with terminology and the basic process. It is applicable to anyone who is involved in the clinical evaluation process. It will be particularly useful to those who are required to input into a clinical evaluation and particularly those who are responsible for producing and writing clinical evaluation reports.
