Clinical Evaluation for Medical Devices On-demand Training Course

Level Requirements Duration 4 hours

Available to book: On-demand elearning Book now

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
On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.

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