Our Rapid Diagnostic Test Manufacturing Process

Our manufacturing process begins with research and development informing innovative design. Global operations bring products to life.

Our Product Manufacturing Process

This is a section dedicated to our manufacturing process.

Innovative Design

Our aim is to change how diagnostic testing is performed in both point of care settings and in the home. We are a world leading rapid test manufacturer creating integrated, user friendly rapid testing solutions and we have commercialised the world’s most consumer-friendly rapid diagnostic test platform that delivers more accurate results.

Conceptualisation

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Design

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Manufacturing

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Introduction to Market

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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.

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Design, Prototyping and Pilot Production

While each platform differs to a degree in its operational capacity, each device in the AtomoRapid™ cassette range includes patented rapid diagnostic test platforms that meet requirements for professional use and self-test applications. The first step of the partnership development pathway is the selection of the appropriate rapid diagnostic test platform. To do this, we conduct a full analysis of your user requirements, with research centring on human factors and user testing to ensure the solution we determine is most appropriate for your needs. We then undertake concept feasibility studies in order to progress to the development of functional prototypes before assisting with the management of intellectual property.

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Verification and Validation

Each platform in the AtomoRapid™ range is customisable to suit your analyte and test strip accordingly. Each platform has full clinical validation and comes with company-wide quality assurance. We utilise an FMEA manufacturing process analysis and can assist and support with regulatory submissions.

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Commercial Launch and Rollout

Our commercial launch and rollout process involves full manufacturing process validation. All of our products are manufactured at our own high quality manufacturing and assembly facilities. As part of our commercialisation process, we offer a full suite of brand, packaging, and marketing assistance. Once your product is launched, our commercial team can be provided continued post-launch support to ensure the best chance of success.

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Re-imagining diagnostics