DCB0129 is a standard applicable to many health technology manufacturers and health IT platforms. The NHS Applicability Guide outlines which organisations are required to undertake and complete the necessary DCB1029 risk management activities. The outcomes can be unclear and Kaleidoscope can support making such determinations.
Clinical risk management activities are an ongoing, iterative process. Kaleidoscope support developers from initiation to deployment. Usually, the time taken to complete the risk management activities varies according to clinical safety work previously completed, other standards met and the nature and complexity of the digital health platform in scope.
DCB0129 is modelled on ISO14971 (Application of risk management to medical devices). However, they are not identical and one of the main differences is the nomination of a Clinical Safety Officer (CSO).
Kaleidoscope support organisations and tailor our clinical safety compliance services to meet your existing processes and to add value to start up companies and international organisations. Please get in touch today for more information about DCB0129 compliance.