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Clinical Evaluation for Medical Devices Training Course

Is clinical evaluation causing challenges for your organisation? Have you received feedback from your notified body that you're unsure how to address?

This training course will provide you with a strong foundation in the principles of clinical evaluation gaining the necessary knowledge, skills, and expertise to create compliant clinical documentation.

Whether you are new to medical devices or looking to strengthen your current understanding, this course will give you an excellent grounding in the EU requirements for clinical evaluation.

Questions?

Clinical Course Overview

  • Online Self-Paced (Pre-Course)

    • What is Clinical Evaluation?
    • Definitions and Key Terminology
    • Clinical Evaluation Process
  • Day 1

    • Recap of the clinical evaluation process
    • Links to other processes
    • Clinical highlights of the MDR
    • Clinical Evaluation Plan & Purpose
    • Types of data and their sources

      Download the full agenda below
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  • Available Dates



    Can't see a suitable date? Speak to a learning expert today at info@leapcompliance.com

What's included?

  • Your own learning portal
  • Course recordings
  • Free 1-2-1 with the trainer
  • Live sessions
  • PDF materials
  • Self paced modules
  • Certificate of completion
  • Access to a community

Learn with a community

Social learning is a powerful tool that allows individuals to learn from one another through observation, communication, and collaboration.

By engaging with others in social settings, people can acquire new knowledge, skills, and behaviors more efficiently. 

Assessments & Feedback

Assessments and feedback play a crucial role in the learning process by providing valuable insights into students' understanding and progress.

Feedback is a valuable tool to reflect on performance, understand strengths, and make necessary adjustments to enhance learning.

Earn a career certificate

After successful completion of this training, your certificate can be used to demonstrate your Clinical knowledge to your employers and Notified Body.

Get in touch with our training experts.

We aim to respond to you within 24 hours. 

Opening Hours:

Monday - Friday: 9:00am - 5:00pm
Saturday - Sunday: Closed
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20+

Years of Experience

5,000+

Attendees Trained

450+

Courses Delivered
- Meet the trainer 

Rod Beuzeval

Rod’s experience has involved providing regulatory strategy from product development to worldwide market registration, creation of technical documentation, implementation of full 13485 compliant QMS systems, standards compliance, clinical evaluations, risk management files, project management and remediation activities. Rod has also spent time working for a notified body, conducting audits against ISO 9001, ISO 13485, 21CFR820, MDSAP, cGMP and GDP.

Frequently asked questions 

Who is this Clinical Evaluation course intended for?

This course is designed for both newcomers to the medical device field and professionals looking to strengthen their understanding of clinical evaluation. It provides essential knowledge and practical skills for anyone involved in the creation of clinical evaluation documentation or remediation of notified body feedback.

What are some of the key learning objectives of the course?

You will learn the full process from start to finish including the key learning objectives below:
- Understanding equivalence and its necessity
- Defining and using the concept of state of the art
- Identifying and utilising safety and performance outcome parameters
- Linking processes such as PMS and Risk Management with clinical evaluation 

Will I receive a certificate after the course? 

After successful completion of this training, you will receive a digital copy of your certificate. Your certificate can be used to demonstrate your Clinical knowledge to your employers and Notified Body.

Do you offer group booking discounts?

We offer group discounts for bookings of 3 or more. Email us at info@leapcompliance.com for your unique discount code. Have a group of 8 or more? Consider running this course in-house. Speak to a training expert today. 

How long is this course?

Our Clinical Evaluation training course is 17 hours long in total. There is 1-hour of self-paced eLearning followed by 16-hours of live interactive training with our industry expert. You also receive access to the course recordings and materials for 6 months after completion. 

Is the course recorded?

Yes, all of our live sessions are recorded so you can go back and revisit the course content for up to 6 months, as many times as you like!