Webinar Details
Wednesday, June 24, 2026 · 15:00
About
As regulatory expectations under the EU MDR continue to evolve, medical device manufacturers face a growing challenge: it is no longer enough to simply collect post-market data; companies must demonstrate that this evidence is generated through structured, traceable, and scientifically defensible processes.
While survey methodologies are traditionally associated with Post-Market Clinical Follow-Up (PMCF), their strategic potential reaches much further. From vigilance follow-up and clinician usability assessments to patient-reported outcomes, training validation, and real-world evidence generation, structured data collection can support broader regulatory and clinical objectives across the entire device lifecycle.
In this exclusive webinar, “Beyond PMCF: Operationalizing Evidence Across the Device Lifecycle”, 1MED joins forces with BSI to offer a unique dual perspective that combines practical implementation experience with official regulatory expectations.
The 1MED team will share firsthand insights on how to design evidence-generation strategies that transform everyday operational interactions into regulator-ready clinical data, showcasing how purpose-built digital infrastructures—such as the 1Survey+ platform—can create scalable, documentation-ready evidence ecosystems.
Complementing this operational view, BSI will provide the Notified Body standpoint on what differentiates standard data from defensible regulatory evidence. They will discuss how evidence is evaluated regarding traceability, data integrity, and its direct linkage to critical regulatory documentation like Clinical Evaluation Reports (CER), PMCF reporting, risk management, and SSCP updates.
Attendees will gain:
- A broader understanding of where regulatory-grade evidence can be generated across the device lifecycle, reaching far beyond traditional PMCF.
- Practical insights into structuring everyday operational data into defensible, inspection-ready evidence assets.
- A clearer view of Notified Body expectations regarding evidence quality, methodology, and data presentation.
- Actionable ideas to move from fragmented data collection toward a scalable, compliant evidence system within your organization.
Agenda
- Introduction of Presenters
- Open Dialog From Expert Panel
- Polls – We Would Like Your Input and Feedback
- Q&A
- Closing Remarks
Duration
- 1 hour
Speakers
- Breda Kearney | Clinical Regulatory Lead – BSI
- Alessandro Malaspina | Head of Regulatory Affairs – 1MED
- John Thomas | Vice President, Clinical Operations & Strategic Delivery – 1MED
Language
- English
Price
- Free
Don’t miss out on this opportunity to gain expert insights into the world of PMCF.
