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SOPHiA GENETICS and Platomics Collaborate to Streamline IVDR Compliance for Clinical Labs

NextEdge Admin

10 Jan 2025

2 min 16 sec

SOPHiA GENETICS , a cloud-native healthcare technology company, is partnering with regulatory automation provider Platomics to simplify EU IVDR compliance for clinical laboratories using SOPHiA GENETICS’ products.

With IVDR Article 5.5 in full effect, labs face stringent documentation requirements, particularly for high-risk NGS workflows. Meeting these demands requires significant time, expertise, and resources. This collaboration introduces a digital solution that streamlines regulatory compliance through the PlatoX® platform, which offers structured files, integrated guidance, automation, and a regulatory knowledge base.

SOPHiA GENETICS’ products will be registered on PlatoX®, enabling instant access to essential product data for technical documentation. Rules-based automation ensures seamless integration of this data into audit-ready reports, while the PlatoX® validation module supports workflow validation.

“At SOPHiA GENETICS, we are committed to providing IVDR-compliant solutions for our customers’ analytical needs. Partnering with Platomics ensures fully documented, validated workflows aligned with IVDR standards,” said Kevin Puylaert, Managing Director, EMEA, SOPHiA GENETICS.

Albert Kriegner, CEO of Platomics, added: “We are thrilled to collaborate with SOPHiA GENETICS to help clinical labs efficiently demonstrate the quality of their genetic tests. Our digital platform simplifies regulatory adherence, ultimately improving testing.”

This solution will be available to customers in the coming weeks.

SOPHiA GENETICS is a cloud-native healthcare technology company advancing data-driven medicine. The SOPHiA DDM™ Platform provides real-time, actionable insights for hospitals, labs, and biopharma institutions worldwide.