News

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Annulment of Decree No. 2016-1716 that was published in the Official Journal of the French Republic on December 13th 2016

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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...

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nexialist is at the MedTech Summit : 19-23 June 2017 in AMSTERDAM

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Are you ready for change? We have finally got there... The Regulations on medical devices and in vitro diagnostic medical devices were...

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Following the debates in plenary on 4th April 2017, the European Parliament adopted on 5th April 2017 (635 votes in favour out of a total of...

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The European Council published, on the 22nd February 2017, the final text of the Regulation on medical devices. This text changes and...

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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.

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Since the 14th April 2016, the European Parliment has adopted the (EU) n°2016/679 Regulation

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ISO 13485 :2016 : Medical Devices – Quality Management System – Regulatory requirements, is available since the 25th of February 2016 .

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Regulation

ANSM

New version of the list of regulatory positions and classifications of MDs and IVDs

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The innovation refund plan is a derogative and transitory way to obtain a payment from the French social security, which aims to make...

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On the 2nd of October 2015, IMDRF published 5 information documents describing the application of some standards regarding medical devices...

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The FDA published « Refuse to Accept Policy for 510(k)s » in August 2015, a new guidance document for medical device manufacturers. It aims...

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