Sonrai Analytics Receives ISO13485 Certification for Medical Device Development

Sonrai Analytics Receives ISO13485 Certification for Medical Device Development

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Sonrai Analytics Receives ISO 13485 Certification for Medical Device Development

The certification is a step towards commercialising Sonrai’s AI diagnostic platform to aid pathologists in analysing cancerous cells from pathology images.
Prof. Darragh McArt, CEO and Founder of Sonrai Analytics with Alice Geaney, Quality and Regulatory Manager, holding the ISO 13485 certificate
PRESS RELEASE 19/10/2023

Sonrai Analytics, a leading Artificial Intelligence (AI) precision medicine company, is proud to announce its ISO 13485 certification for its rigorous quality management system for designing, developing, and producing AI medical devices. This certification underscores Sonrai's commitment to excellence and ensures the safety, performance and quality of its products.

The ISO 13485 certification is the gold standard for the medical device industry. Organisations conforming to ISO 13485 must demonstrate consistent review and validation of product development and manufacturing processes, effective operational procedures, meticulous record-keeping to ensure product traceability and robust post-market processes.

The ISO 13485 certification validates that Sonrai has established comprehensive policies and procedures to meet the stringent requirements for developing and producing medical devices in compliance with international standards. This accomplishment is a significant milestone in Sonrai's journey toward bringing innovative medical devices to market, including its AI diagnostic algorithms for MSI and PD-L1 applications.

Sonrai is developing new AI In-Vitro Diagnostic (IVD) medical devices in collaboration with the Precision Medicine Centre at Queen's University Belfast as part of the prestigious NHSx AI Award programme. The cloud-based devices enable pathologists to upload images of resection and biopsy samples and analyse them using Sonrai's state-of-the-art Artificial Intelligence algorithms. The IVD medical devices will enhance MSI (Lynch Syndrome) testing accuracy and consistency for colorectal cancer, and aid Tumour Proportion Scoring for PD-L1 in Non-Small Cell Lung Cancer samples.

In addition to developing its medical products, Sonrai offers its expertise to partners seeking to navigate the complex landscape of regulated medical device development and deployment.

Prof. Manuel Salto-Tellez, Director, Queen’s University Belfast Precision Medicine Centre of Excellence, said “AI is transforming the way we approach molecular diagnosis of cancer. With ISO 13485, Sonrai enters the selected group of companies able to produce clinical-grade tools that will ensure our cancer patients will live longer and better lives. ISO 13485 will make the PMC-Sonrai partnership more successful in the context of digital oncology.”

Alice Geaney, Quality and Regulatory Manager, Sonrai Analytics said: "At Sonrai, we are dedicated to ensuring the highest quality and safety standards in our medical device development and maintenance. ISO 13485 certification demonstrates our commitment to quality and meeting stringent regulatory requirements."

"Achieving ISO 13485 certification is a testament to our dedication to building a robust quality management system,” said Prof. Darragh McArt, CEO and Founder, Sonrai Analytics. “It aligns with our vision of launching innovative medical products into the market and supporting further growth and commercial success of Sonrai."


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About Sonrai Analytics


Sonrai Analytics, founded in 2018 by Prof. Darragh McArt and Dr. Deva Senevirathne, is an AI precision medicine company with a focus on developing innovative medical devices and solutions. Sonrai’s medical device platform, Sonrai Diagnostics, uses Sonrai’s algorithms to help pathologists detect diseases faster and more accurately. With the ISO 13485 certification and a dedicated team of experts, Sonrai is committed to delivering high-quality, safe, and effective medical products while providing consulting and development services to organisations in the healthcare industry.

With a proven track record, Sonrai has successfully deployed its technology with prominent healthcare businesses across the EU and the US. Additionally, they continue to forge strategic partnerships (including NHS) that will further enhance commercial operations and scale impact.


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About ISO 13485


ISO 13485:2016 specifies requirements for a quality management system where an organisation must demonstrate its ability to provide medical devices and related services that consistently meet customer and applicable regulatory requirements. Such organisations can be involved in one or more life cycle stages, including design and development, production, storage and distribution, installation, or servicing of a medical device and design and development or provision of associated activities (e.g. technical support).


Find out more about ISO13485.

About Sonrai’s AI IVD medical devices


Today, cancer biopsy samples are processed and analysed by pathologists who manually identify cancer subtypes based on their knowledge and experience. Sonrai’s approach will mean that the AI will analyse images of the slides to assist pathologists and help determine treatment options more accurately and consistently.


Find out more about Sonrai’s AI IVD medical devices.

For media enquiries contact:


Chris Martin 

Head of Marketing

Sonrai Analytics

P: 07517428996 


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