Our Product Development Process
Our aim is to change how diagnostic testing is performed in both point of care settings and in the home. We are a world leader rapid test manufacturer creating integrated, user friendly rapid diagnostic tests platforms.
Atomo has an established track record of working with OEM partners in the rapid diagnostic manufacturing space such as NG Biotech, Lumos and Access Bio to deliver quality products and solutions.
With the growing demand for point of care and at-home rapid diagnostics, Atomo can be a launching pad for any lateral flow assay company to diversify and improve their current offerings by leveraging over a decade’s worth of R&D to produce tests that are light years ahead of industry standards.
Our Partnership Development Pathway
Atomo’s robust product development process is compliant to ISO 13485 and FDA CFR 820 and provides a rapid and effective route from design to commercialisation.
Atomo uses a phase gate approach product development process with design reviews at the end of each stage and can support a robust documentation package to support regulatory submissions. Atomo’s team of engineers will work directly with lateral flow manufacturers and assay developers. We strive to understand your rapid test requirements and look to eliminate pain points.