Andrew Lysikatos

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diagnostics medical device point of care solutions product development engineering design manufacturing lateral flow applications isothermal applications pcr applications biomedical fda 21 cfr 820 ivdr software development instrument platforms sensor technologies qms processes iso 13485 verification validation immunoassay molecular applications regulatory submission experience molecular diagnostics biomedical engineering medical equipment manufacturing lateral flow instruments molecular diagnostic instruments isothermal assays quantitative results qualitative results diagnostic platforms point of care diagnostics high sensitivity cartridge integration custom development regulatory compliance fda approval ivd certified assay development multiplex testing sample-to-answer systems portable diagnostic instruments rapid testing solutions biosensor technologies real-time pcr desktop software molecular ivds nucleic acid amplification automation in diagnostics kinetic assay analysis low-cost diagnostics multispectral detection fluorescent immunoassays diagnostic delivery systems research & development biomedical solutions clinical diagnostics test configuration tools assay optimization user-friendly interfaces laboratory information systems gene detection field deployable applications healthcare innovations advanced optical detection data integration touch screen operation wireless connectivity assay result libraries technical documentation iso 13485 certification quality management systems technical support collaborative partnerships healthcare market access hospital & health care mechanical or industrial engineering information technology & services medical devices enterprise software enterprises computer software b2b