Ensuring Regulatory Excellence

Kneu Health proudly announces its successful adherence to a comprehensive set of regulatory and quality standards. These include DTAC, DPST, Cyber Essentials, UKCA, and ISO13485, underscoring our commitment to delivering products and services of the highest calibre for patients and healthcare professionals.

DTAC and DPST Compliance:

Our compliance with DTAC (Digital Technology Assessment Criteria) and DSPT (Data Security and Protection Toolkit) reflects our commitment to meeting NHS clinical safety, data protection, technical security, interoperability and usability and accessibility standards. By meeting these standards, we ensure that we are robust, up-to-date, and aligned with industry best practices.

Cyber Essentials Certification:

In an era where cybersecurity is paramount, Kneu Health is pleased to announce its Cyber Essentials certification. This accreditation demonstrates our proactive approach to protecting both our internal systems and our clients' data from cyber threats. By adhering to Cyber Essentials, we bolster our cybersecurity defence and contribute to a safer digital environment.

MHRA Registered and UKCA mark:

As part of our global market presence, Kneu Health has a UKCA (UK Conformity Assessed) mark and is registered as an MHRA Class I Software as a Medical Device, ensuring that our products meet the regulatory requirements for sale in Great Britain. This commitment underscores our dedication to providing products that not only meet the regulatory expectations of the regions we operate in.

ISO13485 Certification:

The attainment of ISO13485 certification with BSI solidifies our position as a company committed to the highest standards of quality in the medical device industry. This internationally recognized standard for medical device quality management systems ensures that our products consistently meet regulatory requirements, providing our clients with confidence in the safety and efficacy of our offerings.

At Kneu Health, meeting these stringent regulatory and quality standards is not just a requirement; it is a reflection of our core values. By continuously investing in compliance measures, we ensure that our products and services not only meet the expectations of regulatory bodies but also exceed the expectations of our valued customers. We look forward to setting new benchmarks in the industry through our commitment to quality and regulatory compliance.

About Kneu Health

Kneu Health is pioneering a new model of precision neurology for Parkinson's and dementia: care that is proactive, compassionate, and designed for the realities of everyday life. Built on one of the most advanced longitudinal datasets in Parkinson's care — the Oxford Parkinson's Disease Centre Discovery Cohort — Kneu's smartphone-based platform turns structured at-home assessments into actionable insights, enabling clinicians to detect decline earlier and act before symptoms escalate. The technology analyzes speech, movement, memory, and cognition in just minutes a day, using trained models to generate predictive scores and digital biomarkers that inform treatment and care. Kneu is working with leading U.S. health systems to expand access, ease workforce strain, and set a new standard for brain health monitoring.