Clinical Safety Statement for Definition Health Limited
Definition Health has undertaken a formal and structured clinical risk assessment of the LifeBox digital e-pre-operative assessment (ePOA) platform, to ensure compliance with UK safety standard DCB0129. The Clinical Risk Management System provides evidence that the LifeBox digital ePOA platform meets the safety and documentation compliance requirements as laid out in DCB0129, as required by the NHS Data Coordination Board.
As part of the Clinical Risk Management System, Definition Health has identified any clinical risks and provided relevant mitigation measures with a Clinical Safety Hazard Log. The process for identifying said risks can be found in the Clinical Safety Report with accompanying documentation for post-market surveillance of the product and the process for clinical content validation. These documents are updated periodically.
Clinical Safety Officer statement: “The Clinical Safety Officer Mr Sandeep Chauhan confirms that this product, as released and where used as specified, does not include any clinical hazards which could give rise to an unacceptable clinical risk to patients.”
Queries, requests or concerns
To exercise all relevant rights, queries or complaints in relation to this policy, please in the first instance contact heretohelp@definitionhealth.co.uk