The Clinical Safety Officer is accountable for clinical safety and ensuring that effective clinical risk management is carried out by organisations that are responsible either for manufacturing or deploying health IT systems. The Clinical Safety Officer is an expert in areas relating to the assurance of Health IT in scope of the two Clinical Safety standards: DCB0129 and DCB0160. The service supports the client’s customers by
- Named individual fulfilling the role of CSO for your organisation
- Carrying out clinical risk assessments on your health IT systems and producing clinical risk documentation.
- Advising on clinical risk management requirements for Manufacturers of health IT systems. Advise and support the client’s customer with implementing and maintaining the required standards of DCS0129 where necessary.
- Supporting the organisation in establishing a framework within which the clinical risks associated with the deployment and implementation of a new or modified health IT system are properly managed. Advise and support the client’s customer with implementing and maintaining the required standards of DCS0160 where necessary.
The Kaleidoscope team include UK registered health professionals that can fulfil this role for Med-tech and provider organisations. This role will also support your DTAC submissions.