Quality Standards

Make Your Data Secure As It Moves Across Your Organisation

You Have a lot of Considerations - We Take Care of Everything

We build secure, scalable and user-friendly solutions that meet clinical and production-grade standards.

Sonrai’s products are built on Amazon Web Service (AWS) cloud technology, the world’s leading provider. AWS holds various ISO and quality standards including ISO 27001 which relates to security management. Sonrai is a Medical Device Manufacturer with a Quality Management System which has been established against international medical device and data security standards and includes procedures covering data privacy, cybersecurity, algorithm development, software design, testing, validation, quality control, and more.

ISO Standards & CE Mark

In January 2022, Sonrai Analytics began the journey of implementing a Quality Management System (QMS) in line with ISO 13485:2016 requirements. But it doesn't stop there, we are also integrating our data security processes and the quality system requirements of Regulation 2017/746 for in vitro diagnostic medical devices to ensure our business processes meet regulatory requirements and most importantly work for us as a team. We have signed a contract with BSI (UK) to certify our QMS to ISO 13485:2016 requirements, and we have been recommended for our Stage 2 audit which will be held in Dec-2022

Quality Policy

At Sonrai Analytics, our guiding light is to improve diagnosis and treatment for patients worldwide. We do this by enabling discovery for our precision healthcare customers using our innovative AI technology and designing our own AI-based in vitro diagnostic medical devices. We design innovative, safe and effective products that meet regulatory requirements and align to clinical best practices, through our forward thinking quality management system. We encourage our team to ask ‘why’ and identify new ways of working to streamline our business processes to enhance how we work, the products and the service we provide to our customers.

We take care of everything

Each of our customers have different challenges to solve. Get in touch to see how we can help you on your journey.

Data Quality

Sonrai provides end-to-end Data Quality options. These begin with validation at the point of Data Upload or Manual Data Entry, through to MLOps best practices, Project & Data Management, and Quality Control applications to control the final output or qualify findings.

Problems We Solve:

Clinical Algorithms

We provide development services for automated laboratory data management, and biomarker detection including early disease detection and companion diagnostics solutions using innovative machine learning and AI algorithms built to ISO13485 medical device standards

Problems We Solve:

Ask us About Quality Standards

We can arrange quick hands-on demos to walk you through what can be achieved with your data and product pipelines

Security-First Approach

Sonrai enforces Privacy by Design, and Privacy by Default, and provides a full self-service platform that easily allows you to control who can create, view, edit or delete anything on your system.

Problems We Solve:

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