Course description
Understanding Clinical Evaluations
The new Medical Device Regulation, published in 2017 and due to be fully implemented in 2020, will result in significant changes to clinical evidence, with more clinical data being required for device products.
This 4 module course will focus on clinical evaluation reports and will provide you with a comprehensive understanding of literature reviews, proving equivalence, and managing Clinical Evaluation Reports throughout the life-cycle of a product.
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Suitability - Who should attend?
This course is aimed at professionals who are responsible for or involved in clinical evaluations in industry, consultancy, agencies, notified bodies and within CRO’s and may come from the following departments:
- Regulatory affairs
- Clinical development
- Medical writing
- Quality
- Engineers
- Scientists
Outcome / Qualification etc.
- Practical guidance for constructing a clinical evaluation report (CER)
- Discuss and evaluate the impact of the new Regulation on clinical evaluations to ensure you remain compliant and can manage the transition smoothly
- Understand how to assess and analyse clinical data
- Examine how the clinical evaluation report is linked to post market surveillance and the risk management plan
- Comprehend the use of Clinical Evaluation throughout the product lifecycle
Training Course Content
- Module 1: Introduction to Clinical Evaluations
- Module 2: Clinical Evaluation Process
- Module 3: Clinical Evaluation Report
- Module 4: Clinical Evaluation Throughout the Product life-cycle
Why choose PTI
On average, delegates of their online academies said:
Quality of content:
4/5
85% had applied content during the course to their role
Delivery rating:
4/5
Time efficient course, providing all necessary basic information about clinical evaluation and the related regulatory requirements. Also the templates provided are useful.