Quality Standards

Make Your Data Secure As It Moves Across Your Organisation

Alice Geaney
Quality Regulatory Manager

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 information security management. Sonrai aswell as developing innovative AI products for use in research and discovery, is a Medical Device Manufacturer with a Quality Management System (QMS) which has been established against international medical device and data security standards and best practice. Our QMS includes procedures governing data privacy, cybersecurity, algorithm development, software design, testing, validation, software maintenance, and more.

ISO Standards & CE Mark

Sonrai have successfully achieved ISO 13485:2016 certification for the design and development, installation and maintenance of in vitro diagnostics software for digital pathology image analysis. Our certification was provided by BSI (UK).

Our QMS also includes the applicable 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. As we continue on our medical device development journey, we will be engaging with a designated Notified Body for conformity assessment review of our devices and QMS to IVDR 2017/746 requirements.

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 within our certified ISO 13485 QMS.

Problems We Solve:

If you'd like to talk to Alice or another expert from our team, reach out to us

Contact our friendly team to ask us about data quality management

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:

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.
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