Professional Training
5.0 (1 Reviews)

Understanding Clinical Evaluations

PTI, Online
Length
4 weeks
Length
4 weeks
Leave your details so the provider can get in touch

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.

Do you work at this organisation and want to update this page?

Is there out-of-date information about your organisation or courses published here? Fill out this form to get in touch with us.

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

Reviews

Average rating 5

Based on 1 reviews.
Reviews are published according to our review policy.
Write a review!
5/5
Head of Regulatory Affairs
23 Jun 2020
Time efficient course

Time efficient course, providing all necessary basic information about clinical evaluation and the related regulatory requirements. Also the templates provided are useful.

Get Inspired! Watch the Video

Request info

Contact course provider

Before we redirect you to this supplier's website, do you mind filling out this form so that we can stay in touch? You can unsubscribe at any time.
If you want us to recommend other suitable courses, please fill out all fields below and check the box beside "Please recommend similar options"
Country *

reCAPTCHA logo This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
Ads