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Clinical safety and clinical safety management should be a core practice for your organisation to ensure that you meet your statutory obligations for health IT in the UK – DCB0129 and DCB1060.
Our team has decades of direct experience implementing the rigorous NHS standards and can support you in every aspect the process. We’ll ensure that you meet the mandatory standards related to clinical risk management and its application in the manufacture of health IT systems. The DCB0129 standards are now mandatory under section 250 of the Health and Social Care Act 2012.
The 8fold team will ensure that clinical safety is a core practice for your organisation and that the statutory requirements are met. We’ll work with you to create a compliant clinical risk management process and culture, along with the required documentation (i.e., Clinical Safety Case Report, Hazard Log and Clinical Incident Log) to support your application.
A key requirement of the DCB0129 standard is that your organisation has a Clinical Safety Officer (CSO) responsible for the application of the clinical safety process. The CSO must be a suitably qualified and experienced clinician knowledgeable in risk management in clinical domains. We have a team of qualified CSO’s and can offer this expertise if you do not already have a CSO in place.
Check out the information above for details of our products, or book your introductory no-obligation call with our experienced team below to understand your responsibilities for the NHS Data Technology Assessment Criteria (DTAC).
When we have a problem to solve or a complex issue to untangle around IG Adam is there to support us through it. Working with the 8fold team has made our lives a lot easier and built capacity within our team
The team are pleasant, extremely knowledgeable, thorough, prompt in responding to queries and keen to help in any way they could. The work completed on our behalf definitely exceeded expectations.