EU IVDR – Clinical Evidence and Performance Evaluation by Andrea Colombo, MD Compliance Expert – PQE Group The issues exposed in this article will be discussed in “In Vitro Diagnostic Medical Device Regulation 746/2017: what to know to be ready” free Webinar by PQE, on July 8th @11:30 a.m. CET – Register now to secure […]
EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group As EU MDR 2017-745 Regulation deadline is approaching, cybersecurity for Medical Devices has become a main concern for all Networked Medical Devices manufacturing companies. In the video below, we’ll review the most important requirements […]
The art of working after Covid-19: a positive side effect from Covid-19 by Danilo Maruccia and Pierre Crivelli Last decade brought market evolution with itself, and a race for research and development to increase opportunities, optimize costs and improve efficiency in the way leaders do business and manage their companies. This heritage comes from 2008 […]
Smart Working: dealing with IT support implications by Dario Palese Current global health emergency situation is forcing the most of companies to maximize the smart working solution: In order to ensure the same performance whether working in the office or in smart working, IT services need to face this new reality. This means to refocus […]
The European Council and Parliament officially adopted an amendment to Regulation 2017/745, modifying the most of application dates to May 2021.
Why MD Cybersecurity is so important by Danilo Maruccia, Executive Consultant & Business Partner – PQE Group Is Cybersecurity important for Medical Devices? The answer is absolutely yes. But let’s move a bit backwards, to understand the reason why nowadays Cybersecurity has become a main concern for all Medical Devices producers.
National Heart, Lung and Blood Insititute (MD) revealed potential blood and respiratory consequences, Vaping reportedly involved in death and illness cases in Illinois; suspected long-term effects.