Sonrai Analytics, an Artificial Intelligence (AI) precision medicine company, has received ISO 13485 certification for its 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.
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 towards bringing 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 Queens 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 AI 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, added: “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.”
Prof. Darragh McArt, CEO and founder, Sonrai Analytics, commented: “Achieving ISO 13485 certification is a testament to our dedication to building a robust quality management system. It aligns with our vision of launching innovative medical products into the market and supporting further growth and commercial success of Sonrai.”