Medical Technology: Use Cases

Long-term development partner for LIS systems – a highly integrative task

Laboratory information systems are the hub and integration platform for all technical processes in the laboratory. They integrate a variety of medical devices and processes and thus allow efficient interaction within the laboratory and with the system landscape of the clinic or laboratory community. PTA’s own special combination of technical and IT expertise enables a world market leader to outsource the product development of its internationally distributed products.
From technical specifications to design, development, quality assurance, roll-out and 3rd level support, PTA covers much more than the classic software development process. The integration of instruments into laboratory workflows is taken into account through close cooperation as early as the development phase of the devices, interfaces are defined at an early stage and the efficient implementation of new device functions in the integrated laboratory environment is made considerably easier through early expansion of IT. This makes us one of the few IT service providers with comprehensive laboratory IT competence in Germany for more than 15 years.

New certification strategy and SW development according to PTA ISO 13485 certified QMS enables further operation according to MDR (Medical Device Regulation)

An established patient data management system (PDMS) is subject to new criteria for approval due to the amendment of the MDR. A diagnosis- and therapy-critical functionality of the current PDMS is not sufficiently developed and documented after the re-evaluation. By creating a certification strategy and redeveloping the critical component using the PTA’s quality management system certified according to ISO 13485, a declaration of conformity can be issued that ensures continued operation as a medical device.

New approval of medical devices – evaluation of the documentation and comprehensive support for revision and implementation of the specifications

Established manufacturers of medical devices such as suction pumps, obstetrical equipment and infusion pumps must re-approve their products under the new EU Medical Device Directive MDR (EU 2017/745). After an assessment of the existing documentation by the PTA, gaps in risk management acts, requirements, specification, verification and validation documentation will be identified and closed according to an agreed procedure. The PTA provides support in documentation, but also in verification and the establishment of a document management system.

Systems Engineering – Transformation of a start-up into a productive organisation at an equipment manufacturer

A good idea is turned into a product by a highly qualified team from a wide range of disciplines working together effectively and flexibly. This is how prototypes and first routine samples of a device are created, which integrates hardware, software and AI components.

As the product becomes more professional, organisational units such as sales, R&D, production and support must be created that work together efficiently – a transformation process takes place. The PTA advises on this and additionally supports the implementation through practical collaboration, e.g. as Product Owner and Scrum Master.