Able Care Logo
Evidence

Compliance & Regulatory Status.

Able Assess meets stringent regulatory and data protection requirements across the UK.

Therapist reviewing Able Assess results with a patient on a tablet

Trusted credentials

I2
ISO 27001
UGC
UK GDPR Compliant
GC
GDPR Compliant
N2A
NICE 2025 Aligned

Regulatory and compliance detail

MHRA Registration

GripAble Ltd is registered with the Medicines and Healthcare products Regulatory Agency (MHRA) as a UK manufacturer of medical devices. Registration confirms that the manufacturer complies with UK device registration and post-market surveillance requirements, and that products meet applicable safety and performance standards under the UK Medical Device Regulations 2002 (as amended).

UKCA / CE Marking

Able Assess carries UKCA and CE marks confirming conformity with UK and EU health, safety and environmental protection standards. Conformity assessment has been completed in accordance with the applicable Medical Device Regulation (MDR) requirements for marketing and sale across Great Britain and the European Economic Area.

ISO 27001

Able Care holds ISO 27001 certification for its information security management system. This internationally recognised standard requires documented policies, risk assessments and controls covering data confidentiality, integrity and availability. Certification is maintained through annual surveillance audits conducted by an accredited certification body.

UK GDPR and Data Protection Act 2018

Able Care processes personal data in accordance with the UK GDPR and the Data Protection Act 2018. Technical safeguards include encryption at rest and in transit, role-based access controls, audit logging and documented breach notification procedures. Data processing agreements are in place with all sub-processors, and data subjects can exercise their rights to access, rectification, erasure and portability through documented procedures.

NICE NG249 Alignment

Able Assess aligns with the National Institute for Health and Care Excellence (NICE) NG249 guidelines on falls assessment and prevention. The platform supports the recommended multifactorial risk assessment approach, capturing objective functional measures that NICE identifies as central to falls prevention in older adults.

Questions about compliance?

Our team can provide regulatory documentation, data processing agreements and technical security details.