Evira

Clinical promise.
Practical confidence.

A care model needs to work for the people delivering it. Explore clinical fit, capacity and governance together, before agreeing how to proceed.

Governance

Procurement-ready documentation

Confirm current certification status with us directly before relying on it in a business case or approval.

Full standards table and documents →
Assessment

DTAC

Digital Technology Assessment Criteria evidence pack available for your assessment team.
Clinical safety

DCB0129 & DCB0160

Manufacturer clinical risk management documentation, and support for your own DCB0160 deployment work.
Data security

DSP Toolkit

Data Security and Protection Toolkit submission, with data processing agreement and DPIA support.
Device

CE marked

Class I medical device under MDR.
Security

Cyber Essentials

Certified, with information security policies available on request.
Data protection

ICO registered

UK GDPR compliant. Patient data is processed in the UK and EU.

Responsibilities

Who is accountable for what

Clarity here saves months later.

Your organisation

Data controller. Responsible for assessment, treatment, clinical decisions, documentation, and local information governance approval.

Evira

Data processor and device manufacturer. Responsible for the platform, device, security, and manufacturer clinical risk management.

Shared

Agreeing the review routine, escalation triggers, and what is recorded in the patient record. Set this before the first family starts.

Implementation

A staged start, with training first

Implementation runs in stages so the team is confident before families are onboarded.

01

Walkthrough

We go through the treatment flow and your current care process together.

02

Agreement and data handling

Data processing agreement, DPIA and information security review in place.

03

Team training

Clinicians are trained in the method and the clinical interface.

04

First patients

You start with a small number of families and scale from there.

Need the full evidence pack?

We can send the published papers, the DTAC evidence pack and the clinical safety documentation together, so your team can assess them in one pass.

Request the evidence pack →