Software As a Medical Device (SaMD)

Transforming algorithms into regulated medical software. We support the development of Software as a Medical Device (SaMD) across a range of clinical applications, from diagnostic algorithms to decision-support tools.

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Whether you’re working with image analysis, digital biomarkers, or cloud-based health platforms, we can help you navigate regulatory pathways, ensure software quality, and translate your code into a fully compliant, CE- or FDA-ready product. Our ISO 13485-accredited systems and adherence to IEC 62304 software lifecycle guidance provide a solid framework for SaMD development, allowing us to support everything from early feasibility through to technical documentation and clinical validation.

·Clinical Calculators
·Embedded Software
·AI Image Analysis
·Digital Biomarkers
Applications
Cloud-based Platforms
Suitable for IOS/Android

Our Technologies

Utilising quantum dot, latex particle, colloidal gold and Europium conjugation, amplification, and detection methods our technologies can detect samples by absorbance, luminescence, fluorescence intensity, time-resolved fluorescence, and immunoturbidity.

Within our advanced biochemistry labs, we develop and optimise the reagents with traditional ELISA methodologies initially within 384-well or 1536-well microplates, allowing us to titre the reagents, assay linearities, precision and detection sensitivity using 1-5µl sample volume.

Our Expertise

We combine a highly qualified and experienced team, with a seamlessly integrated Quality and Project Management System to develop medical diagnostics products at our accredited biohazardous, instrumentation, and manufacturing facilities.

That is why we typically deliver products in under 4 years with around 90% reduced costs.

Our expertise

Our Team

Our team consists of Research Scientists, Product Developers, Development Scientists, Instrumentation Engineers, Mechanical Designers, Manufacturing Engineers, Clinical Researchers, Sales, and Marketing Managers, Production Technicians, and Logistics Professionals.

We develop, manufacture and commercialise hardware, software, firmware, mechanical design, biochemical reagents, interpretation algorithms, connectivity and user interface aspects of test cartridges, analysers, QC Materials, and electronic accessories.

Our expert team

OUR TECHNOLOGIES

Our highly qualified team combine their expertise across a range of technologies and disciplines along with their seamlessly integrated approach to develop medical diagnostics products at our accredited facilities.

Lateral Flow Technologies

ELISA

Molecular Assays

Mechanical and Solid State Systems

From ECG technologies, viscosity measurements, microscopic vision systems and mechanical techniques, Medtechtomarket has developed a number of products that deliver diagnosis with a direct measurement of the patient or on the sample itself.

Photometric and Fluorescence-Based Assays

At Medtechtomarket, we have wide-ranging experience in developing technical optical test cartridge formats and instrumentation to deliver highly sensitive colormetric, turbidity or fluorescence assay detection systems for measuring single biomarkers, enzyme assays and panels.

Immunochemistry

From state-of-the-art microfluidic immunofluorescence to traditional lateral flow technologies, we employ a range of immunological techniques to determine markers for clinical chemistry and haematology point of care diagnostic applications.

Microfluidics

Utilising passive and active continuous-flow microfluidic approaches to channel blood and reagent samples into micro-cuvettes, flow channels, reaction chambers, electrochemistry and MEMS sensors we are able to measure a wide range of biochemical markers in a number of clinical applications.