Beyond PMCF: Operationalizing Evidence Across the Device Lifecycle

As regulatory expectations under the EU MDR continue to evolve, manufacturers are increasingly challenged not only to collect post-market data, but to demonstrate that evidence is generated through structured, traceable, and scientifically defensible processes. While surveys are often associated with Post-Market Clinical Follow-Up (PMCF), their potential reaches far beyond traditional PMCF activities. From vigilance follow-up and clinician usability assessments, to patient-reported outcomes, training validation, investigator-initiated studies, and real-world evidence generation, structured survey methodologies can play a far broader role in supporting regulatory, clinical, and strategic objectives across the device lifecycle.

In this webinar, 1MED will share its experience as a MedTech CRO working with manufacturers to design and implement evidence-generation strategies that transform everyday operational interactions into regulator-ready clinical and performance data. Drawing on practical examples across multiple use cases, 1MED will explore how manufacturers can better operationalize evidence capture—ensuring that data generated across functions is methodologically sound, auditable, and aligned to intended use, risk management, and clinical evaluation requirements. The discussion will also highlight how purpose-built digital infrastructures, including platforms such as 1Survey+, can help manufacturers create scalable, documentation-ready evidence ecosystems.

Complementing this operational perspective, BSI will provide the Notified Body view on what differentiates useful data from defensible regulatory evidence. Through regulatory insight, observed industry challenges, and practical examples from assessments, BSI will discuss how evidence is evaluated in relation to traceability, methodology, data integrity, and linkage to regulatory documentation such as Clinical Evaluation Reports (CER), PMCF reporting, PMS activities, risk management, and SSCP updates. Together, 1MED and BSI will offer a unique dual perspective—combining implementation experience with regulatory expectation—to help manufacturers better understand how operational data can be converted into credible, inspection-ready evidence assets.

Attendees Will Gain:
-- A broader understanding of where regulatory-grade evidence can be generated across the device lifecycle — beyond traditional PMCF, including vigilance follow-up, clinician feedback, training validation, patient-reported outcomes and real-world evidence initiatives.
-- Practical insight into how operational data can be structured into defensible evidence assets
-- A clearer view of Notified Body expectations for evidence quality and presentation
-- Learn from real-world examples and case experiences shared by both 1MED and BSI.
-- Actionable ideas for operationalizing evidence generation within your organisation — moving from fragmented data collection activities toward scalable, regulator-ready evidence systems that strengthen compliance, inspection readiness, and long-term regulatory confidence.