A Practical Guide to Writing Summaries of Safety and Clinical Performance
Date/TimeMarch 14, 2023
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
Rachel Gibbs, BSc, PhDPrincipal Regulatory Consultant
Rachel Gibbs has 15 years’ experience in the medical device and pharmaceutical industries, and also as a Senior Auditor for a leading European Notified Body. Rachel joined NAMSA in 2021 and has used her knowledge of MDR auditing to advise Clients regarding regulatory and clinical strategies, undertaking Gaps Assessments and writing MDR submission documents.
Rachel started her career at the Medicines and Healthcare Products Regulatory Agency (MHRA) working on drug variation and renewal licensing before moving back into academia to conduct a PhD in Immunology. Thereafter, Rachel moved into the pharmaceutical industry, joining 3M Healthcare, working on the development of metered dose inhalers and nasal sprays for U.S. Food and Drug Administration (FDA) and EMEA drug applications. With the opening of 3M’s Skin and Wound Care Laboratory, she transitioned into the medical device industry and was actively involved in new product development for a range of wound care devices, inclusive of design control, risk management, manufacturing upscaling and process validation. Rachel then moved to BSI in 2015 as a Senior Auditor and Clinical Evaluation Specialist involved in product conformity assessment to the Medical Device Directive (93/42/EEC), and subsequently audited against the Medical Device Regulation ([EU] 2017/475).