20. April 2018

ISO13485 certification

PTA with ISO certification in medical IT since January

Certification enables PTA to offer additional services

PTA has held the ISO13485 certificate in the field of medical IT since January 2018. This means that the Mannheim-based consulting company now has the opportunity to provide qualified services, particularly in the development of medical software. This ultimately benefits customers in particular.

Certificate is mandatory for diagnostic devices

ISO13485 regulates quality management in the design and manufacture of medical devices and is necessary as soon as they are used to treat patients or diagnose diseases. It regulates the establishment of processes that ensure that the risk of a medical device for the patient is correctly assessed and thus ensures 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, among other things. Until now, in these cases there has been close cooperation with the customer who manufactures the device. This meant that he had to bear the entire quality risk.

The certification now opens up new opportunities for the PTA. From now on, the company can offer customers who do not want to set up their own quality management system to develop the software for their medical device to create it in accordance with PTA quality management. This makes it easier for the PTA to offer its services in the field of health IT:

  • Consulting and organization of business processes as well as analysis, design, development, testing and implementation of software systems on behalf of customers.
  • Cross-industry specialist and technical IT services along the entire software life cycle.
  • Consulting, support and services for individual and standard software projects.

Ultimately, this benefits customers in particular, as they can concentrate exclusively on the hardware while the PTA takes care of the software. The IT service provider thus sets itself apart from consulting firms that do not have this certification and offers its customers even better cooperation.

Dr. Thomas Steinmann

Sector Manager Life Science

Related articles

Digital document management with IDP

According to a survey that we conducted together with the market researchers at Statista, only just under half of the companies surveyed use digital solutions to manage their documents intelligently. The potential for increasing efficiency in this area is enormous.

Learn more

Jetzt Kontakt aufnehmen

Zum Umgang mit den hier erhobenen Daten informieren wir in unserer Datenschutzerklärung.

Contact now

We provide information on the handling of the data collected here in our privacy policy.

Download file

We provide information on the handling of the data collected here in our privacy policy.