Point-of-Care devices are small, portable devices used in clinics, hospitals, and medical practices. Since these devices send measurement results via WLAN to the hospital information system, keeping them updated is crucial. The IT department does not want to collect all devices for security updates. The customer's solution allows remote updates via WLAN. The new quality management system requires comprehensive risk management. PTA conducted the introduction and training of risk managers and supported the first two releases to ensure that risk management according to ISO 14971 aligns with agile processes.
Supplement
First, PTA conducted a baseline assessment with the project team to identify which standards were already met and where improvements were needed. PTA then created an action plan to address the open points. PTA intensively supported the first release after the introduction of the new quality management system. Subsequently, PTA and the customer reviewed what went well and identified areas for improvement. For the next release, PTA was on standby to intervene quickly and efficiently if problems arose.
Subject description
This product allows hospitals to monitor and keep their Point-of-Care devices updated. It also improves preventive maintenance actions by providing better data quality. This enables precise tracking of which device performed how many measurements and how long it remained on the charging stations.