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 […]
Forbes BusinessCouncil Is an Invitation-Only Community for Successful Business Owners and Leaders Florence – Italy, February 23rd — PQE Group, quality services provider for Life Sciences, has been accepted into the Forbes Business Council, the foremost growth and networking organization for successful business owners and leaders worldwide. Gilda D’Incerti was vetted and selected by a […]
Rome, November 17th – Danilo Neri, Vice President Operations for PQE Group, has been nominated Member of ISPE Italy Affiliate Board delegated for International Relationship. ISPE (International Society for Pharmaceutical Engineering) is the largest non-profit association in the world dedicated to pharmaceuticals, and, with over 18,000 members and an operation in 90 countries, it deals […]
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.
New offices opened in Boston (MA, USA), Chandigarh (India), Gdansk (Poland) and Mons (Belgium). PQE Group expands its borders by embracing new countries in Europe such as Belgium and Poland and increasing its presence in the United States and India.
A call for Smart Industry by CHIST-ERA on Big Data and Process Modelling A programme for European Coordinated Research on Long-term Information and Communication Technologies (ICT) and ICT-based scientific challenges, CHIST-ERA annually calls for research proposals on key emerging topics. In 2017, the brief was ‘Big Data and process modelling for smart industry’. Partnering with […]
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.
On September 26th, 2019 the CMDh published the notice “Information on nitrosamines for marketing authorisation holders” asking to all Marketing Authorization Holders (MAHs) of human medicinal products containing chemically synthesised active pharmaceutical ingredients to evaluate the risk of the presence of nitrosamine impurities in their products. This includes generics and over-the counter (OTC) products.