Ready to Use
'Reader as a Service' App
Ready to use 'reader as a service' app configured for your test, designed for development and QC work.
What We Offer
Our Solutions
We have three main ways to support your project:
Ready to Use
Software Development Kit
(SDK)
Software development kit to allow you to build your own applications around our technology or embed in an existing app.
Custom Development
Service
Custom development service — we will build an entire app and any associated web services to support your use case.
Why Go Digital
Digital Diagnostic Benefits
There are various reasons why lateral flow test manufacturers want to make their assays digital - but here are some of the more common ones:
Remove human interpretation
Because we all have different eyesight, previous experience and personal bias
Open up quantitative testing
Where numbers matter more than simple yes/no
Record the result
When you need proof that tests were done, where, when and by who
Understand your customer
Opening direct communication channels to customers, or obtain analytics insights on test use
Get data for post market surveillance
And regulatory compliance
Help your users to get testing right
From accurate timing, interactive instructions, to clear interpretation and follow up
Whichever industry you are in, from clinical, veterinary, food chain testing, to industrial or environmental - we have helped customers like you understand how to maximise the value from mobile diagnostics.
Compliance & Standards
Quality & Regulatory Commitment
At Novarum DX, we understand the critical importance of quality and regulatory compliance for our
clients, many of whom are medical device manufacturers operating in highly regulated markets.
ISO 13485:2016 Certified
We are proud to be ISO 13485:2016 certified, demonstrating that our organisation maintains a robust Quality Management System (QMS) for the design, manufacture, and servicing of medical devices.
This internationally recognised standard is a testament to our commitment to quality, safety, and regulatory compliance. Our QMS provides a framework to meet regulatory requirements in the UK, EU, USA, and other global markets.
Software Development to IEC 62304
Our software team is highly experienced in developing software in accordance with IEC 62304, the international standard for software as a medical device. This ensures our software solutions meet the rigorous requirements for safety and effectiveness demanded by regulators worldwide.
All our projects require risk management so we are very familiar with ISO 14971 as well as other standards you may need to comply with e.g. IEC 82304 (health product general requirements), IEC 62366 (usability engineering), and of course IEC 81001-5-1 for security.
Deep Industry Experience
With combined experience of nearly 100 years in regulated industries, our team brings together expertise from science and engineering backgrounds, covering a wide range of medical devices and in vitro diagnostics (IVD).
Our roles have spanned product development, operations, manufacturing, quality, and regulatory affairs—ensuring comprehensive, effective, and compliant solutions for our clients. This breadth of practical experience means we truly understand what our customers need to achieve and are well equipped to support them on their journey, and we have individuals with over 25 years personal experience in delivering it.
End-to-End Support
Whole Lifecycle Support
Whole Lifecycle Support
Transforming an assay to a digital approach is not a one off activity, so wherever you are in the process of developing or launching an assay we know it's a major commitment and we can support you: tools to assist assay and reader optimization, support in field trials, and ongoing QC.
Our RARE platform aims to help you throughout your lateral flow product lifecycle. whilst we are committed to supporting clients with SDK or custom solutions on an ongoing basis.
Why Choose Us
Built for Your Success
Flexible Integration
Whether you need a ready-to-use app, an SDK to integrate into your platform, or a fully custom solution, we adapt to your needs.
Regulatory Expertise
Our team understands the complexities of medical device regulations and ensures compliance with international standards.
Proven Technology
Over a decade of experience in mobile imaging for lateral flow tests with patented solutions deployed worldwide - from the simplest rapid tests to quantitative multiplexed assays.
Ongoing Support
From initial development through deployment and beyond, we support your product throughout its entire lifecycle.