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Safety Reporting for Medical Devices Part 1

Level:
Foundation
Area:
Medical Devices
Code:
MDF6
Duration:
03:00:00
Workshop profile:
This workshop is for everybody who wishes to embark on safety reporting/ writing for medical devices as well as those that want to learn more about the specifics of safety reporting to gain a better understanding about processes, regulations and definitions (e.g. about the differences between adverse events and device deficiencies). No previous experience is required.
Objective:
Safety reporting for medical devices is an emerging field that can utilize the skills of medical writers and several companies have started to hire medical writers for that purpose. In addition, the knowledge gained in this workshop will deepen the insights of adverse events that may also be beneficial in writing documents such as clinical investigation plans.
Content:
Part 1 (of 2) provides a general introduction to safety writing including key areas medical writers may be involved in, definitions, relevant regulations and guidelines, IMDRF coding, and safety reporting including the Clinical Investigation Summary Report Form, and individual and summary reports. The second part will touch base on topics such as literature review for trending, patient narratives, safety plan and coding, clinical events committee and data safety monitoring board guidelines, risk management documents, post-market surveillance plans, PSURs, SSCPs, and the safety part of informed consent forms, clinical investigation plans and instructions for use,