Xpedite Diagnostics GmbH

About

We challenge the status quo in sample preparation by striving to replace aging classical products for DNA isolation and RNA extraction by cost efficient and easy-to-use kits that facilitate fast extraction of RNA and DNA for rapid molecular biology analysis in high-throughput labs as well as at the point of care.

We bring molecular technologies to the point of care by providing our customers with tools for a full molecular analysis workflow. For that, we engaged in a distribution partnership on RAA reagents, a versatile rapid isothermal amplification technology for real-time fluorescence detection, end-point detection and lateral-flow strip detection.

We ensure regulatory compliance of IVD products using lean approaches by leveraging our deep knowledge in Regulatory Affairs and Quality Management to guarantee compliance with regulatory requirements and to minimize the time-to-market for our IVD medical devices by applying case-specific regulatory strategies.

We also offer our expertise through consulting services to other IVD companies. We help in developing a lean regulatory strategy and in reducing time, effort and costs for compliance to the European IVD Regulation (IVDR) 2017/746.

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Keywords

rapid nucleic acid extraction, dna isolation, rna extraction, recombinase aided amplification, swiftx toolbox, ivd regulatory consulting, quality management consulting, contract development, oem manufacturing

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