PTA since January with ISO certification in medical IT
certification enables PTA to offer further services
Since January 2018, the PTA has held the ISO13485 certificate in the medical IT sector. Thus the Mannheim-based consulting company now has the opportunity to provide qualified services, especially in the development of medical software. In the end, it is primarily customers who benefit from this.
Certificate is mandatory for diagnostic devices
ISO13485 regulates quality management in the design and manufacture of medical devices and is necessary once they are used to treat patients or diagnose disease. It regulates the establishment of processes that ensure that the risk of a medical device to the patient is correctly assessed, thus ensuring that no patient is harmed by its use.
PTA is certified – the customer benefits
As a service provider, PTA develops software for use in such diagnostic devices. Until now, there has been close cooperation with the customer who manufactures the device in these cases. This meant that the customer had to bear the entire quality risk.
The certification now offers PTA new opportunities. From now on, the company can offer customers who do not want to build up their own quality management system to develop the software for their medical device, to create it according to the PTA quality management system. Thus the PTA can offer its services more easily in the area of Health IT, that is:
- Consulting and organisation of business processes as well as analysis, conception, development, testing and introduction of software systems on behalf of customers.
- Interdisciplinary professional and technical IT services along the entire software life cycle.
- Consulting, support and services within the scope of individual and standard software projects.
Ultimately, customers benefit the most, as they can concentrate exclusively on the hardware, while the PTA takes care of the software. The IT service provider thus differentiates itself from consulting firms that do not have this certification and thus offers its customers an even better cooperation.