During this course (2 x ½ day) you will get a good insight into the key steps of performing a Clinical Evaluation and how to fulfill the requirements. The course is focused on practical aspects of Clinical Evaluations with group discussions, case studies and examples.
Course description
This course provides practical guidance on how to perform a Clinical Evaluation, how to write both plan and report, and discussions on how to make it fit your device while meeting the requirements. We will go through the stages of the Clinical Evaluation process (scoping, identifying data, appraise data and analysis) including practical tips on how to do the systematic literature review.
During the course you will also discuss how to grade and weigh the validity of clinical data. We will also highlight the major changes in relation to the new Medical Device Regulations (MDR). Post market clinical follow-up (PMCF) is discussed, with rationale for when it is not needed.
Stages of a clinical evaluation and references to sections and appendices of this document
Course outline
- Scoping and Planning
- How to adapt the evaluation to your device
- Define your PICO- summarize in literature search plan
- Identifying pertinent data
- How to perform a systematic literature review
- Practical tips when performing literature search
- State-of-the-Art discussion
- Appraisal of clinical data
- Useful tools, templates, and tables
- Consider risk of bias, scientific validity, relevance, and weighting
- Analysis of clinical data
- Consider compliance, key requirements
- Post market clinical follow-up and justifications
- MDD, MEDDEV 2.7/1 rev compared to the MDR requirements
- Case studies, with examples of software as a medical device
Learning objectives
At the end of this course, participants should have a better understanding of how to define clinical data and how it is used to support a device’s intended use and claims.
Furthermore, the participant should be able to describe the clinical evaluation process, including the stages under MEDDEV 2.7/1 rev 4 and its role in the product life cycle, including writing the plan and report. In addition, a basic understanding of how to perform a systematic literature review as well as how to collect data for a state-of-the-art (SoTA) overview.
Who should attend
The course is suitable for persons working in the field of medical devices with regulatory, quality, risk management, and clinical investigations who needs to write, review, and/or audit clinical evaluation reports.
Prerequisites
- You should have basic knowledge of how to perform scientific data base searches
- You should have experience in writing regulatory reports /medical writing
- You should have at least 6-12 months experience of working in the regulated industry (medical device or pharmaceutical industry).
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