At the core of our process is the full development of a product, encompassing specifications, risk management, technology verification, product validation testing, manufacturing validation and clinical studies. We do everything in the technical file.
From the first prototypes to the full validated manufacture of your product, we work closely with our clients and drive the program through each stage of the innovation pathway. Through our trusted partners in the UK and our FDA accredited contract partners in Asia, we can support our clients with longer-term large-scale commercial manufacturing, or the transition of the production to their own facilities.
We deliver regulatory assessments and submissions, road-map planning, and complete the IVDD/IVDR CE marking and FDA 510(K) applications and ensure your product is compliant with all applicable global regulations to ensure each technology is ready for launch in the chosen market.