Publications nexialist

News and updates

GMED designated in accordance with the MDR

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...

How the MDR will impact your regulatory watch

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...

Successfully preparing for remote audits of your quality management systems

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...

News and Updates

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...
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

News and Updates

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...

read more
Regulation

GMED designated in accordance with the MDR

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...

read more

How the MDR will impact your regulatory watch

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...

read more
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
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...

read more
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...

read more
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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