Publications nexialist

News and updates

The COVID-19 pandemic and face masks: overview of the current situation

As the world continues to be hit hard by the COVID-19 pandemic, the European Union is facing shortages of necessary personal protective equipment (PPE) and medical devices, such as face masks. Given the surge in demand for these products, legislative measures have...

Latest and final version of the regulation on in vitro diagnostic medical devices

The European Council published, on the 22nd February 2017, the final text of the Regulation on medical devices. This text changes and replaces the proposal for a regulation published on the 9th august 2016, which had obtained a political agreement on the 20th...

nex’inform

Regulatory intelligence solution

nex’SOS

Emergency solutions

Corporate

BToHeath Day

Nexialist is taking part in the BToHeath Day, come and meet us on the 24th of November 2016 in Marseille at the Intercontinental Hotel. Nexialist is taking part in the BToHealth « The biomedical market within your reach !” day on the 24th November 2016. Do you want to...

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Digital Health

Regulation on the protection of personal data

Since the 14th April 2016, the European Parliment has adopted the (EU) n°2016/679 Regulation The Regulation (EU) 2016/679 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data was adopted by The...

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Electrical devices

Publication of 5 new information documents by the IMDRF

On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...

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Clinical evaluation
General news

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Regulation
Process/ Production

How to prepare for the DuPont Transition Tyvek

The transition from Legacy Tyvek® to Transition Tyvek® will take longer than planned. This means that manufacturers will have more time to carry it out. Discover here all the available tools to help you maintain compliance. DuPont™, the company that manufactures...

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Quality

ISO 13485:2016 is available since the 25th of February 2016

ISO 13485 :2016 : Medical Devices – Quality Management System – Regulatory requirements, is available since the 25th of February 2016. This standard should be published in national legislation before September 2016. The working group who has wrote this standard...

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Risk management

Publication of 5 new information documents by the IMDRF

On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...

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Unique Device Identification System (UDI System)

Publication of 5 new information documents by the IMDRF

On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices in the countries, or group of countries, which are members of the IMDRF: Australia, Brazil, Canada, China, Europe, Japan, Russia...

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Innovation

French High health authority: innovation refund plan

The innovation refund plan is a derogative and transitory way to obtain a payment from the French social security, which aims to make easier the access to new technologies and products. It can concern medical devices (MD), in-vitro diagnostic medical device (IVDMD) or...

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PMS / PMCF

MedTech Summit : 19-23 June 2017 in AMSTERDAM

nexialist is at the MedTech Summit : 19-23 June 2017 in AMSTERDAM We invite you to: Come and meet us at stand no. 6 from the 19th – 21st June Hear Julie Coste, Associate Director, speak on Post Market Surveillance a 12.00 on the 20th June. You are still in time to...

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