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12.08.2025-13.08.2025
Online course: Clinical Investigation – Supporting the Clinical Evaluation of a Medical Device
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| An important part of the technical documentation of a medical device is its clinical evaluation, which, according to the MDR, should be based on a review of the relevant literature of identical or similar medical devices or the results of the medical device’s clinical investigation and the results of post-market clinical follow-up of the medical device. For the auditor of a clinical evaluation, the results of the clinical investigation of a given medical device are essential for a positive assessment of its safety and efficacy. It is therefore very important that the clinical investigation of a medical device is planned and conducted in accordance with good clinical practice and ISO 14155 standard. |
Aim
This workshop will provide you with an overview of the key elements of the clinical investigation of a medical device that influence the credibility of the results and, consequently, the clinical evaluation of the medical device. Therefore, the workshop presents in more detail:
- the phases of a clinical investigation,
- the key documents of the investigation, which include:
- the approved investigation plan,
- traceability of the conduct of the investigation,
- data processing and analysis, and
- presentation of the results of the investigation.
The knowledge you gain will enable you to:
- monitor the planning and conduct of a clinical investigation of your medical device,
- determine the indication(s) or intended clinical use of your medical device; and
- identify potential weaknesses in the emerging clinical evaluation, especially for those medical devices that may have multiple intended use, whereas the clinical investigation can often evaluate only one intended use.
Content
- Types of clinical investigations with medical devices
- Key phases of a clinical investigation
- Clinical documentation – clinical investigation plan (protocol), patient information and informed consent (ICF), clinical data collection form (CRF), patient diary, investigator brochure, investigation marketing materials
- Clinical investigators
- Patient recruitment strategy
- Procedure for obtaining the opinion of the Ethics Committee and the approval of the competent authority for medical devices
- Initiation of the investigation
- Supervision of the conduct of the investigation
- Challenges and obstacles in the conduct of the investigation
- Data collection, processing, and analysis
- Preparation of the investigation report
- Conclusion of the investigation
| After the first meeting, participants prepare a short, focused paper – a draft clinical investigation plan for a medical device and present it to the group during the second part of the training. |
Welcome
- Medical device manufacturers.
- Medical device developers.
- Responsible persons for the preparation of a clinical evaluation.
- Anyone wishing to acquire or upgrade their knowledge of the clinical investigation of a medical device.
Additional information: Bojan Varga, phone: +386 1 477 81 08, e-mail: bojan.varga@siq.si
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