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...
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...
Are you ready for change? We have finally got there... The Regulations on medical devices and in vitro diagnostic medical devices were published on 5th May, 2017 in the Official Journal of the European Union. We can now put a name (and finally ... a number) to these...
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 713 voters) the final versions of the Regulations on medical devices (MD) and in vitro diagnostic medical devices (IVDMD)....
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...
Annulment of Decree No. 2016-1716 that was published in the Official Journal of the French Republic on December 13th 2016 05/02/2018 Decree n°2016-1716, regarding the « medical device characteristics summary » was annuled by the French Council of State on april, 26th...
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...
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...
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...
New version of the list of regulatory positions and classifications of MDs and IVDs On January 22, 2016, the ANSM published a new version of the “FAQ” on regulatory positions and classifications of medical devices and in vitro diagnostic medical devices (dated...
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
