Med eTrax are an innovative provider of digital systems to support Acute and Community Health organisations. In 2016 Med eTrax became aware of the importance of complying with the mandatory UK Health IT Safety Standard SCCI 0129. Med eTrax already had a robust Quality Management System and Security Strategy in place but this didn’t yet extend to meet the specific safety requirements of the SCCI 0129 Standard.
As a small to medium enterprise, specifically employing a clinician to act as a Clinical Safety Officer was unrealistic. Instead Med eTrax engaged the services of Safehand to help perform the safety analysis and construct the necessary documentation using their tried and tested processes.
The partnership resulted in the key SCCI 0129 materials being issued without interrupting any of Med eTrax’s exiting commitments. Med eTrax were able demonstrate to their customers that they had invested significant time and effort in systematically managing risk through safe design. In addition, Med eTrax found that by introducing a small number of additional test scripts, they were able to evidence further rigour in assuring specific critical functions.
Chief Executive of Med eTrax, John Hopkins commented, “Working with Safehand has allowed Med eTrax to complete the necessary testing and documentation to meet the needs of SCCI 0129 with our effecting our client focus and without the substantial cost of employing a clinical safety officer. In completing the work supported by Safehand and its detailed knowledge it has also allowed us to integrate the safety processes in to our existing Quality Management system (ISO 9001/2015) allowing us to better manage the risk of software change going forward.”
Safehand Consulting Limited
Company number: 10012494
VAT No: 234182721