Clinical Evaluation for Medical Devices eLearning

Level Specialist Duration 4 hours

Available to book: On-demand elearning $345 Book your place

This intensive course enables you to gain a detailed understanding of the clinical evaluation process for medical devices against the requirements of the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents.

On-demand - training that’s even more flexible

BSI’s on-demand courses are market-leading and available 24/7. Developed by top subject matter experts, they contain the same high-quality content you will find in our tutor-led training, but with the added benefit of being able to learn at your own pace and at any time.

How will I benefit?

The course will help you:

Identify the requirements of clinical evaluation against the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents
Determine when clinical evaluation is undertaken and the frequency of updates
Interpret and communicate the key requirements and expectations of medical device clinical evaluation to your organization
Apply the clinical evaluation process for medical devices within your organization

On completion of this training, you’ll be able to:
- Identify the key requirements for clinical evaluation according to the MDR, MEDDEV 2.7/1 Revision 4 and relevant MDCG guidance documents
- Explain the principles of clinical evaluation
- Outline the stages of the clinical evaluation process and documentation requirements
- Define how clinical evaluation is performed, including details on clinical evaluation plans (CEP), demonstration of equivalence, identification and appraisal of data and analysis of clinical data
- Determine when a clinical investigation is needed for your device
- Explain the post-market clinical follow-up (PMCF) requirements
- Define the requirements of a clinical evaluation report (CER)
Clinical and Regulatory Affairs Professionals, Medical Device R&D Engineers and Scientists
Familiarity with your own device, clinical safety and performance issues.

Awareness of:
- General Safety and Performance Requirements (Annex I), Clinical Evaluation and investigations (Annex XIV and XV) of the MDR - EU 2017/745
- MEDDEV 2.7.1 Revision 4 and relevant MDCG guidance documents
This is an online, interactive on-demand course.

Courses are available 24/7 and you can learn at any time and from any place that suits you – you just need an internet connection.

You can learn as fast or as slowly as you want to. You can also take breaks at any time in the course and pick up where you left off when you are ready to continue.

During the access period, you can go back and repeat parts or all the course to refresh and reinforce what you have learned.

The course content is both detailed and engaging, with explanations, activities, and knowledge checks to enhance your learning.
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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