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The certification ISO 13485:2016 “Medical Devices – Quality Management Systems” identifies a standard for the Quality Management System specific for companies [...]

BREXIT transition period update. The British government decides not to request an extension of the transition period for leaving the European [...]

This article will discuss the main differences between Consultancy and Training and how they have changed due to (or thanks to) [...]

After the vote of the European Parliament and the European Council, the postponement of the new regulation on Medical Devices MDR [...]

By urgent procedure with 693 votes to 1 and 2 abstentions, last April 17 the European Parliament voted the proposal of [...]

Last April 3, 2020 the European Commission officially proposed to postpone by one year, until May 26, 2021, the application date [...]

The Covid-19 medical emergency has led to the necessity to find Medical Devices and personal protective equipment (PPE). In response to [...]

Because of the Covid-19 sanitary emergency, the European Commission proposed to delay the application date of the MDR (UE) 2017/745 by [...]

The Medical Device Regulation (MDR), published in May 2017, marked the beginning of a transition period that for Medical Devices will end up next [...]