Pregnabit – a mobile teleCTG device and its new software have successfully passed recertification audit carried out by TÜV NORD Polska Sp. z o.o. Thus, the company has managed to maintain the CE mark, confirming compliance with the essential requirements set out in Directive 94/42/EEC concerning medical devices. Recently, Nestmedic’s flagship project has been enriched with new functionalities, including real-time examination. Another important step forward is certification of PregnaView CTG visualiser as a new medical device.
The recertification audit of the Pregnabit teleCTG system carried out by TÜV NORD Polska Sp. z o. o. was successful, and so the CE mark for Pregnabit as a medical device was maintained. Nestmedic was also able to maintain ISO 13485 certification – the Quality Management System for Medical Devices. The audit confirmed the company’s adherence to international standards that aim to guarantee the safety and high quality of products, as well as their compliance with legal requirements and customer expectations alike. The Pregnabit device was certified with a new functionality, i.e. real-time examination. The audit also confirmed compliance with the essential requirements set out in Directive 93/42/EEC of a new medical device: PregnaView, which makes an important component of the Pregnabit platform, and is used to visualise CTG records according to medical standards.
Currently, Pregnabit makes it possible to perform CTG tests in real time, which extends the use of the telemedical system as a whole. The device can be used not only by the patient herself at home, but also by doctors and midwives in non-hospital environments. The new functionality has been created to enable CTG examination in locations where access to medical care is difficult and during home births.
We are constantly working to improve our mobile CTG device, Pregnabit – we tune in to the expectations of our customers and implement them in practice. Maintaining CE and ISO 13485 certificates and meeting the requirements set out in European standards for medical devices confirm the high quality and safety of our innovative telemedical products, comments dr n. med. Patrycja Wizińska-Socha, Nestmedic CEO.
