Our ISO 15189 compliant laboratory houses microbiology and molecular biology testing facilities, and our experience working under ISO 13485 means we are perfectly suited to help you develop your medical diagnostic technologies and validate your products.
Our testing laboratory was set up to assist in the COVID-19 pandemic, and we have expanded our scope to include other microbiological and molecular clinical test methods under our ISO 15189 compliant quality management system.
Our team are experienced in developing and validating medical diagnostics under the ISO 13485 regulations. We can offer packages for validation and verification of products building a robust technical file including pilot clinical data.
Our sequencing services cover a range of activities including 16S Microbiome. Our key focus is vaginal health and we are happy to discuss other sequencing needs to assist in your research.
From bench top testing through clinical pilot studies to regulatory systems, we can assist in bringing products to market at any stage, speeding up commercialisation without compromising on quality and safety.
E-mail: info@agilelifesciences.com
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