Lateral-Flow Assay Workshop

Designing IVDR-Ready Diagnostics with Confidence

ELLECOM SWISS AG is pleased to participate in the upcoming Lateral-Flow Assay Workshop, organised by Cytiva in Istanbul, Türkiye from 19 October to 21 October 2026.

At the workshop, Antje Tandetzky will represent ELLECOM SWISS AG as a speaker, contributing ELLECOM’s regulatory perspective to discussions on lateral-flow assay development and in vitro diagnostics.

On 20 October, her presentation, “Designing IVDR-Ready Diagnostics with Confidence,” will focus on how regulatory requirements can be considered alongside product development to support a structured and efficient pathway towards IVDR compliance.

Her contribution will highlight the importance of connecting assay development, validation, performance evidence and regulatory strategy from an early stage, helping IVD manufacturers build the evidence required for the European market.

Connecting Lateral-Flow Development with IVDR Requirements

Successful IVD development requires more than demonstrating that an assay works. Intended purpose, assay design, analytical and clinical performance, risk management, usability, manufacturing processes and supporting evidence all need to be considered as part of the regulatory pathway.

ELLECOM supports IVD manufacturers in connecting these requirements throughout product development, helping teams identify regulatory considerations early and establish the evidence required for technical documentation and conformity assessment.

Exchanging Knowledge Across the Diagnostics Community

The workshop brings together subject-matter experts from academia and industry and provides an important platform for discussing current developments, scientific challenges and regulatory perspectives in lateral-flow assays and in vitro diagnostics.

We look forward to exchanging knowledge and experience with experts from across the lateral-flow community and contributing ELLECOM’s regulatory perspective to the development of innovative diagnostic solutions.

ELLECOM - Connecting diagnostic development, scientific evidence and IVDR compliance.