We are happy to confirm that, upon request, our Tiara9 and ELMS2 customers can now access Ethitec’s Clinical Risk Management documentation online.

Although DCB0129, and the corresponding DCB0160, standards have been in effect for a period of time, historically clinical safety has not been an issue that has been raised by our customers. More recently, however, Ethitec has started receiving regular requests concerning the DCB0129 status of our healthcare products, presumably due to the focus on health and social care organisations needing to complete DCB0160 for the systems they employ. As a consequence, we have made efforts to formalise our position.

Consulting with 8fold Governance, long-time experts in this field, we have reviewed and updated our products and Clinical Safety and Clinical Risk Management processes to ensure we have the materials required to prove our compliance with DCB0129. This is an ongoing process, with Ethitec’s Clinical Safety Officer regularly reviewing updates to the systems and maintaining Hazard and Clinical logs.

Should you have need to look at these documents, please let us know and we will grant you access.