LFAction! Symposium & Workshop - New Dimensions in Rapid Testing

Advancing IVD Regulation and Validation for Lateral Flow Diagnostics

ELLECOM participated in the LFAction! Symposium & Workshop - New Dimensions in Rapid Testing, organised by Vellap Diagnostic GmbH in Weimar, Germany, bringing together experts from research, development, manufacturing, regulatory affairs and the lateral flow diagnostics industry.

At the event, Antje Tandetzky from ELLECOM addressed participants on IVD regulation and validation, with a particular focus on the regulatory considerations that manufacturers should integrate into the development of lateral flow assays.

Her contribution focused on how early consideration of regulatory requirements, critical materials, supplier variability, performance and usability can support effective validation and a structured pathway towards regulatory compliance.

The event also provided an important opportunity for exchange with experts and manufacturers working across the lateral flow diagnostics and rapid testing community.

Connecting IVD Development with Regulatory Requirements

For IVD manufacturers, regulatory compliance is more than preparing technical documentation for submission. Regulatory and validation requirements need to be considered throughout product development, from intended purpose and assay design to critical materials, risk management, performance evaluation, usability and manufacturing processes.

ELLECOM supports manufacturers in connecting these requirements with practical product development and validation activities, helping to establish the technical and performance evidence required to support their IVD regulatory pathway.

Building Connections Across the Lateral Flow Community

The event represented another important opportunity for ELLECOM to exchange knowledge with specialists from across the lateral flow value chain and to contribute regulatory and validation expertise to the development of innovative rapid diagnostic technologies.

We value the exchange with the organisers, participating experts and manufacturers and look forward to continuing these discussions within the international IVD and lateral flow diagnostics community.

ELLECOM – Connecting IVD development, validation and regulatory requirements.