SIQ: Online-Workshop: Clinical evaluation of medical devices by literature

This workshop will be in English and is part of our new academy cooperation with the Slowenian notified body SIQ!

About the training

Clinical evaluation is mandatory for all medical devices under the MDR. An important part of the clinical evaluation is the thorough review and evaluation of published clinical data on your medical device and analogous devices. Conducting a systematic literature review helps support the intended use of your device and confirm its safety profile by demonstrating that it poses minimal risks or that its benefits outweigh the potential risks. A comprehensive analysis of published clinical data in peer-reviewed publications, medical guidelines and published reports can also show that your product is superior to existing alternatives. Therefore, a high-quality leterature review with pragmatic approach is needed to produce quality data output for your clinical evaluation report.

Intention

In this workshop you will learn the most important steps for preparing a clinical evaluation of a medical device based on a literature search.

Content

• Optimization of your search term strategy
• Identification of relevant publications
• Reasons for inclusion and exclusion of published data/notes/articles/reports
• Evaluation and weighting of clinical data
• Effective summarization of data
• Use of multiple data sources
• Documentation of references

Methodology

Examples of best practice, exchange of experiences, work on concrete practical examples.

Costs

• Standard: 475,00 EUR (excl. VAT)
• Get your special 10 % en.co.tec-discount with this code: encosiq10
  
• incl. seminar documents as PDF and a certificate of participation.

Your Trainer

Dr. Mojca Fir holds a PhD in chemistry and has more than 8 years of experience in human clinical research, mainly for medical devices and food supplements. As a clinical trial project manager, she is familiar with and involved in all phases of clinical trial development, from designing the clinical trial protocol and supporting documentation, obtaining a favourable ethics committee opinion and approval from the competent authority, conducting and monitoring clinical trials in healthcare facilities, data collection and analysis, and preparing the final clinical trial report. She works as director and clinical trial project manager in a CRO (Clinical Research Organisation).

Location: ONLINE

The online workshop will take place in a live online e-classroom. Up to two days before the implementation, registered participants will receive a link to the online training. Participants need a computer with a microphone and a camera, as well as access to a reliably functioning internet connection to participate in online training without interruption.