A positive result of the recertification audit
The AioCare with mobile apps and a panel for specialists has successfully passed a recertification audit carried out by TÜV NORD Polska Sp. z o. o. at the end of 2019. The device has maintained the CE mark, confirming once again the fulfillment of essential requirements set out in the Medical Directive 93/42 /EEC about medical devices. Recently, we have been working on developing a panel for doctors, thanks to which they will be able to conduct personalized therapy of patients, based on reliable home spirometry measurements of the lungs. We also maintained the certification of the ISO 13485:2016 management system – Quality Management System for Medical Devices, thus meeting international standards for the safe production of medical devices. This is particularly important in the light of regulatory changes to be introduced by Regulation (EU) 2017/745 of the European Parliament and Council of 5 April 2017. Our goal is to guarantee the safety and high quality of products and their compliance with the latest legal regulations. We are already preparing for the changes upcoming along with MDR.