A Practical Guide to Writing Summaries of Safety and Clinical Performance
When it comes to medical documentation, it is important for the inclusion of complex technical information to be easily comprehended by patients or other lay-persons, who are often the intended audience. This is especially true for EU Medical Device Regulation (MDR) Summaries of Safety and Clinical Performance (SSCPs), and is considered a key attribute.
Join NAMSA for an engaging and practical webinar, led by one of our former Notified Body auditors, where we will review MDR SSCPs from the Notified Body perspective with a focus on demonstrating how to write clear, concise and informative SSCPs.
Attendees of this webinar can expect to learn how to:
- Summarize clinical data without the SSCP being a re-write of the Clinical Evaluation Report (CER)
- Tackle clinical gaps
- Translate the regulatory requirements of MDCG 2019-9 into meaningful clinical communication – for both the clinician and the lay-person
- Ensure the SSCP remains manageable and readable while being continually updated with Post Market Clinical Follow-Up (PMCF) data
- Understand the practicalities and complexities when authoring SSCPs
- Understand the practical routes for lay-person assessment
- Maintain SSCPs as they grow year on year with PMCF data