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Tracking of samples
Project duration: 1 year, 8 months
Brief description
This software solution simplifies blood collection in two essential ways. First, it makes the transport route trackable, allowing users to see the temperature exposure of the sample. Second, it enables patients who need regular blood tests to collect their own blood at home and record it in the app. The sample is then picked up and taken to the lab. Once the result is available, both the patient and the attending doctor can see it. The application is used by various user groups, including patients, lab staff, dispatchers, and medical personnel.
Supplement
The system is a cloud-based solution, allowing third-party suppliers to connect their systems via REST-API and receive the necessary information. A web app is also available for dispatchers and patients. This software is not directly a Software as Medical Device according to ISO 62304, but future developments might bring it under this regulation. To prepare for this, PTA was tasked with setting up and managing the risk management to meet the requirements of ISO 62304 and ISO 14971.
Subject description
The main problem with blood samples is that many become spoiled during transport, leading to inaccurate lab results. This always requires qualified personnel to assess sample quality. About 60% of samples that lose their required quality do so due to improper storage or transport. During the time between collection and pickup, the medical staff can be alerted to unacceptable temperature fluctuations. During transport, the dispatcher can also be informed if the samples are no longer within the permissible temperature range.
Overview
- Industries medical technology
- Specialist tasks Compliance, ISO 14791, ISO 62304, risk analysis, Risk Management
- DV tasks customised software new development
- System environment Cloud Computing
- Procedure model agile software development
- Standard software JIRA
Project period01.01.2023 - 31.08.2024
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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