This one-day course offers a robust overview of the clinical evaluation process for medical devices against the medical device regulation (MDR - EU 2017/745), MEDDEV 2.7/1 revision 4 and relevant MDCG guidance documents.
Designed for clinical professionals with a base understanding of general safety and performance requirements, this training teaches you how to explain the key principles of clinical evaluation. During this stage of your learning journey, you will gain skills to determine when your device requires clinical investigation and you will leave with a full grasp of the clinical evaluation process.
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
Pedagogical objectives
- Fully grasp clinical evaluation requirements in line with the Medical Device Regulation (MDR - EU 2017/745), MEDDEV 2.7/1 revision 4 and relevant MDCG guidance documents
- Able to explain key requirements and expectations of medical device clinical evaluation to your organization
- Apply the clinical evaluation process for medical devices within your organization
Skills to be acquired
Upon completion of this training, you 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)
Targeted audience
Clinical and Regulatory Affairs Professionals, Medical Device R&D Engineers and Scientists.
Pedagogical, technical and framing means
Course materials including :
- Introduction to the training, detailed programme and security assignments
- Course presentation, theory and activities/ role plays
- Answers to the activities
- Videos
- Additional documents, distributed during the sessions, to use for the activities
- Attendance sheet to be signed
Assessment specifics
- Questionnaire to assess the knowledge at the end of the training
- Customer survey
What is included ?
- Course materials, provided electronically
- Letter of attestation
- Official certificate
Do you need more information?
If you have any concerns, please do not hesitate to contact our service department on the following numbers:
Telephone: 01 89 79 00 40
Email: training.france@bsigroup.com Or via the webchat service on our website: bsigroup.com
You will be put in touch with our team if necessary.
