The French notified body GMED (number 0459) has just been designated in accordance with the MDR ! It is the 15th notified body to successfully pass the designation milestone. Its designation perimeter is among the most expanded. It is available on the NANDO database...
Have you thought about the impacts of the Regulation (EU) 2017/745 on your regulatory and normative watch? The Regulation (EU) 2017/745 on medical devices, together with the ISO 13485: 2016 standard, require manufacturers to implement a monitoring system in order to...
Current travel restrictions, combined with the necessity to maintain regulatory certification programs, have driven certification bodies to find alternative methods of assessing the conformity of medical device manufacturers’ quality management systems (QMS). Various...
Welcome in the news and updates section! You will discover here everything about the MD industry and even more. Our Knowledge Management team will present you its bests articles & the Marketing our corporates news. You will find easily all your looking for in this...
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...
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...
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)....
UDI System
Quality
Digital health
Regulation
Electrical devices
PMS / PMCF
Clinical evaluation
Process / Production
Risk management
