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Accelerating Medical Device Innovation, Globally.
At Bioexcel, we partner with medical device and IVD companies to navigate the complex journey from prototype to regulatory approval with confidence. As a global Clinical Research Organization (CRO), we specialize in EU MDR, IVDR, US FDA, and CDSCO compliance — providing tailored solutions that meet the highest standards in safety, performance, and post-market surveillance.
Whether you’re launching a new device or updating your technical documentation, Bioexcel supports you every step of the way — from clinical investigations, PMCF planning, and CER/BER development to materiovigilance and ISO 13485 QMS implementation.
We’re also the creators of XcelTrials – a purpose-built EDC platform that streamlines PMCF, PMS, and regulatory documentation with real-time insights and global compliance tracking.
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