IT project database
Convince yourself of the range of our IT consulting services and our unique expertise, which we make transparent for you with our IT project database. With the help of filters and keyword searches, you can search through 4620 IT projects that we have successfully completed with our customers.
This semi-automated device needed a product update after a long and successful time on the market. One reason for the update was the new In-Vitro Diagnostic Regulations (IVDR). Another reason was that …
The customer's product is a compact benchtop solution for clinical chemistry tests in laboratories that want to analyze up to 50 samples per day. As the solution has aged, PTA was tasked …
In preparation for the re-certification of the IT service provider (customer) according to ISO 13485, tools used by the customer in the creation of life science software are to be validated. The …
A mobile application for Android and iOS systems is being developed to control a medical hardware component. This component (dongle), provided by the customer, is used for the thermal treatment of symptoms …
To revitalize the customer's legacy products for the market, PTA takes charge of revising cybersecurity measures. The existing strategies, initially implemented during development, are no longer sufficient to adequately address current attack …
In preparation for the re-certification of the IT service provider (customer) according to ISO 13485, tools used by the customer in the creation of life science software are to be validated. The …
In order to ensure the continued market approval of existing products, the technical files are reviewed and, where necessary, remediated and supplemented to establish conformity with the Medical Device Regulation (MDR, (EU) …
In this project, the project management for a team of customer and PTA employees in the field of software development for laboratory diagnostics is taken over. The team is organised, controlled and …
The customer wants to develop a new device for screening blood reserves. The PTA advises on software and system architecture as well as regulatory issues. …
Evaluation of several Application Lifecycle Management Systems …
As part of the revision of the Quality Assurance Procedures (QVA) for Product Risk Analysis of IVD products, the tool has been significantly modified to meet the new requirements. For this purpose, …
The management system certification according to ISO 13485 requires, among other things, the validation of all (software) tools if they contribute to the product or the technical documentation. A central IT system …
In previous surveillance audits of the customer by its Notified Body, non-conformities were raised that the customer's process descriptions were partly outdated and did not meet the requirements of 93/42/EEC (MDD) and …
The customer develops an innovative automation system for diagnostic high-throughput laboratories. The current customer process for laboratory planning and product deployment cannot be applied directly to the new laboratory automation system. The …
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 …
The customer is facing a surveillance audit by his notified body. In a previous audit, it was criticized that the process descriptions and references of the customer's QM process landscape are in …
To support about 3000 migrations from different legacy laboratory information systems (LIS) towards a strategic product of the customer, 5000 - 25000 configuration values need to be transferred per scenario. Aim of …
The current quality control (QC), which is only able to handle numeric (quantitative) QC results, is extended to be able to handle alphanumeric (qualitative) QC results as well. Thus a broader range …
Our customer, an IT Service provider delivering medical software to its clients, is facing some major findings from a supplier audit. Points of concern are basically the processes requested by the ISO/EN …
The customer wants to develop a test system for home use and connect it to a network of applications. During the project, customer requirements will be elicitated. Based on this, a first …
To facilitate the setup of new instances of a laboratory information system (LIS), a migration interface is being developed which consists of two components: an export/import module in the LIS and a …
Quality assurance and approval of Potentially Reportable Incidents (PRIs) and Quarterly Complaint Check. …
After changing the strategic IT product, the relevant software tools should also be adjusted to fit the new target product. Within the context of a further development of the existing migration tool, …
A reagent management module as well as a quality control according to the RiLiBÄK guidelines and tailored to the customer's reagent management will be developed. Quality control is semi-quantitative and qualitative. The …
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