REF. CL01 – INTRA / INTER
CLINICAL
COURSE DESCRIPTION
The demonstration of a product’s compliance with the general requirements must include a review of the literature. This review, which is part of the preparation of a clinical investigation or evaluation, must be methodical and documented.
DURATION
1 day / 7 hours
IN-PERSON
VIRTUAL CLASSROOM
OBJECTIVES
- Become familiar with the terms and vocabulary
- Understand the regulation’s requirements in terms of clinical evaluations
- Learn the basics for the conduct of a literature review (state of the art and clinical data specific to MDs)
TARGET TRAINEES
- Medical Device manufacturers
- Medical Device development or market operators
PREREQUISITES
No prior knowledge required
TRAINING RESOURCES
- PowerPoint presentation handed out at the end of training
- Examples tailored to the company’s products
- Work is based on applicable regulations and the MEDDEV 2.7/1 guidelines
- Quizzes
COURSE CONTENT
Participants welcomed and presented/Course objectives/Presentation of the course content.
- Clinical evaluation: context and definitions
- Terms and definitions
- Regulation (EU) 2017/745
- MEDDEV 2.7/1 revision 4 guidelines
- Become familiar with the different stages of a clinical evaluation
- Identify clinical benefits and claims
- Identify the points to be presented in the state of the art
- Literature review: What data? How to analyze it?
- Use databases and search engines
- Determine selection criteria for references
- Define a method to select references
- Assess the reliability of the evidence presented in the scientific articles selected
- Practical examples
- Summary/Q&A
- Course evaluation and conclusion
EVALUATION METHODS
- Course evaluation quiz
- Satisfaction survey
- Attendance certificate
This training is assessed based on an evaluation of each individual’s acquisition of knowledge via quizzes during and at the end of the program (success criteria >= 80%).
