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Category: MedTech

PQE Insights - Tech Transfer

How to perform a robust Vaccine Technology Transfer in a challenging era

How to perform a robust Vaccine Technology Transfer in a challenging era

Operational Technology and Cyber Security must walk hand in hand

Operational Technology and Cyber Security must walk hand in hand by Danilo Maruccia […]

IVDR 746

EU IVDR – Clinical Evidence and Performance Evaluation

EU IVDR – Clinical Evidence and Performance Evaluation by Andrea Colombo, MD […]

EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers

EU MDR 2017-745: New Cybersecurity Requirements for Networked MD producers by Danilo […]

The art of working after Covid-19: a positive side effect from Covid-19

The art of working after Covid-19: a positive side effect from Covid-19

Smart Working: dealing with IT support implications

Smart Working: dealing with IT support implications by Dario Palese Current global […]

EU MDR deadline postponed may 2021 - PQE insights

EU MDR deadline officially postponed to 2021 due to covid outbreak

The European Council and Parliament officially adopted an amendment to Regulation 2017/745, modifying the most of application dates to May 2021.

Cybersecurity for Medical Devices risks and vulnerabilities

Why MD Cybersecurity is so important

Why MD Cybersecurity is so important by Danilo Maruccia, Executive Consultant & […]

vaping suspected long term consequences health risks and death. man vaping. need for regulation

Vaping suspected for health consequences, needs regulation

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.

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