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Monitoringsoftware for patient data documentation
Project duration: 4 years
Brief description
The customer is successfully operating a patient data documentation management system (PDMS) within the DACH region. Triggered by the adaptation of the european medical device regulation (MDR), the need is identified to secure the operation of the product by a officical certification as a medical device. The solution for this need is the development of a independent medical software system, that verifies and evaluates calculations for clinical data. PTA is supporting the whole application lifecycle of this software, including the consulting towards a certification strategy and develops the software according to the constraints given by ISO/EN 62304 and ISO/EN 62366 as well as the overarching norms ISO 13485 and ISO 14791.
Supplement
PTA develops a software, that interacts with the existing system communication of the PDMS by identifying relevant HL7 messages and evaluating the content according to configured rules. The client system is windows based and is comparable to the function of anti-virus software. The server part enables the user to configure the rules as well as securing the system operation and its traceability (audit trail).PTA is developing the product under the guidance of its own (ISO 13485 certified) quality management system and consults the customer with respect to regulatory or quality related processings.
Subject description
Within the current PDMS it is already possible to add rules and categorisations to clinical data and to use the repsective results. This functionality is assessed to be critical to patient safety, while neither developed nor documented according to the regulatory requirements of a medical software. By extending the system with an automated monitoring and evaluation, it is possible to declare conformity and securing the operation as medical device.
Overview
- Industries health care
- Specialist tasks electronic documentation, eletronic data exchange, hospital, ISO 13485, ISO 62304, medical devices, patient records, test management
- DV tasks customised software new development
- System environment Client/Server, host systems, Middleware, technical data processing
- Procedure model iterative procedure
- Development/ test tools MS Team Foundation Server TFS, MS Visual Studio, Resharper, SpiraTeam, Unity,
- Standard software docuvita
Project period08.01.2019 - 31.12.2022
Contact
PTA GmbH Head Office
Weberstraße 2-4
D-68165 Mannheim
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