This one-day 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.
The course is designed to provide you with an understanding of the clinical evaluation process including details on the regulatory requirements, the principles of clinical evaluation, how they are performed and documented.
Practical activities throughout the day provide the opportunity to apply your skills in order to perform a clinical evaluation within your organization upon completion of the course.
Online training courses: Connected Learning Live
You can attend this training course classroom based and online. Do you prefer the convenience of an online training course? View here for the available dates or read more about Connected Learning Live.
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Who should attend?
Clinical and Regulatory Affairs Professionals, Medical Device R&D Engineers and Scientists.
Prerequisites
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
Delegates will 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)
Practical information
- It's a 1-day course
- The training and materials will be provided in English
- Lunch and drinks are included for the classroom training
- On completion, you’ll be awarded an internationally recognized BSI Training Academy certificate.
For further information regarding reduced rates at the hotel where the training is being conducted please contact training.nl@bsigroup.com or 0031-(0)20 346 0780.
