All articles
3/04/2023
MD: the role of pre-clinical data in technical documentation (MDR & ISO 13485 :2016)
Medical devices shall achieve the performance intended by their manufacturer and shall be designed and manufactured in such a way
1/03/2023
We broke records at the Eco Sport Challenge!
On March 18th, the Lyon-based Efor teams participated in a unique inter-company challenge with great enthusiasm: picking up as man
11/02/2023
Efor US. is born
Something is coming …Before closing 2022 marked by growth, resilience and starting a new year rich in projects, we are laun
7/02/2023
Extension of the Ecovadis Label
The Efor group reinforces its CSR approach and actions, as recognized by the extension of the silver medal awarded by Ecovadis. We
18/01/2023
Opening of the new Basel offices
Welcome in Basel !!!!Last week our teams met to inaugurate our new offices in Basel.It was the perfect opportunity for the Swiss t
15/12/2022
How to implement the IEC 60601-1 standard when placing medical electrical equipment on the market
ScopeIEC 60601-1 is the umbrella safety standard for medical electrical (ME) equipment. As its name suggests, ME equipment re
12/12/2022
Efor X UTBM Partnership – Together for Telethon
Last December 1st, the Efor and UTBM Junior teams decided to join forces and energy to support the 2022 Telethon.The event include
30/11/2022
DM/DMDIV: Analysis and trend reports during post-marketing surveillance
The Medical Devices Regulations (MDR) 2017/745 and the In Vitro Diagnostic Medical Devices (IVDR) Regulation 2017/746 require the
10/11/2022
Medical and scientific writing
Medical and scientific writing encompasses a range of writing activities in the areas of medicine and science, whether they focus
20/10/2022
Changes to medical devices (MDs / IVDMDs)
Once CE marked The life of a medical device is not a long, quiet river… Who has never attended a team meeting on a change t
4/10/2022
EU GMP Annex 1 update: what has changed, and what are the impacts?
EU GMP Annex 1 on good manufacturing practice defines rules for the manufacture of sterile medicinal products. Based on a 2008 ver
15/09/2022
AI for the detection of diseases – Image analysis
In recent years, artificial intelligence has played a prominent role in the area of health.Its booming use has to fulfil various t
14/09/2022
Launching Virtual Reality Training Programs
Tree, the training center of the Efor Group, reinforces its expertise and innovation capacity through immersive virtual reality tr
9/08/2022
Advertising for medical devices (MDs / IVDMDs)
Since 1 January 2013, regulations on advertising have applied not only to pharmaceutical companies, but also to manufacturers of m
7/07/2022
DMDIV: Gradual implementation of regulation (EU) 2017/746
Since 26 May 2002, the placing on the European market of all IVDMDs has been subject to compliance with Regulation (EU) 2017/746 &
7/07/2022
MD marketing in the USA: what are the steps of the 510(k) submission procedure?
Why market a medical device in the United States?The USA is currently the largest medical device market, accounting for 45% of the
21/03/2022
Focus on the propensity score
When you are implementing some of the studies managed by Soladis, you may need to calculate a “propensity score”.What
6/01/2022
Why is it important to precisely calculate sample sizes before carrying out studies?
Whether in clinical or industrial studies, numerous standards are emerging to justify sample sizes.This is the case, for example,
15/12/2021
Discovering our -omics activities
To demystify this area of activity and offer you the opportunity to better understand it, our biostatistics and bioinformatics -om
20/11/2021
BREXIT: Market access to Great Britain and Northern Ireland
Access to the European and UK markets for health products has changed dramatically since the UK left the European Union on 31 Janu
17/11/2021
The headquarters of Efor Group is moving.
The Lyon-based teams of Efor and CVO-EUROPE are relocating to the brand new premises at Racing Park in Champagne au mont d’o
16/11/2021
Post-Market Surveillance (PMS), Post-Market Clinical Follow-up (PMCF/PMPF) and PMCF/PMPF Studies
Post-Market SurveillanceFor any MD (including IVDMDs) placed on the market, made available on the market or put into service, manu
29/09/2021
UDI : Keys dates
One of the new features of Regulation (EU) 2017/745 (MDR) and Regulation (EU) 2017/746 (IVDR) is the implementation of the UDI sys
21/09/2021
Evaluating the biocompatibility of medical devices
Background information Evaluating the biocompatibility of medical devices (MDs) is of major importance as it ensures the safe
27/07/2021
Data Integrity – The adventures continues
Why data integrity?Data are central to all our interactions, communications and strategic decision-making. In the pharmaceutical a
19/07/2021
No mutual recognition agreement between the European Commission and Switzerland, what are the impacts for manufacturers?
One of the keys to facilitating bilateral trade between the EU and Switzerland is the Mutual Recognition Agreement (MRA). This agr
12/07/2021
Clean up day : together to clean
As part of the Quality of Life at Work week and the inter-company challenge that our teams participated in last June, we decided t
24/06/2021
Inter- company Connected challenge – Quality of life at work week
Together we are stronger and we go further…During the Quality of Life at Work week held from June 14th to 20th, Efor and CV
25/05/2021
The implant card, a new requirement for implantable MDs: are you ready?
Article 18 of Regulation (EU) 2017/745 (MDR) sets out the information to be supplied to the patient with an implanted device and i
12/04/2021
Evimeria – The Health and Well-being Platform by Efor Group
Evimeria is the innovative health solution developed by the Soladis by Efor teams. Its purpose is to accompany users on a daily ba
12/11/2020
More stringent regulations for non-medical products
Cosmetic contact lenses, liposuction devices, wrinkle fillers, tanning booths, lasers, and equipment for tattoo removal and hair r
12/11/2020
UDI and EUDAMED to facilitate the monitoring and traceability of medical devices
To improve and facilitate the monitoring and traceability of medical devices, Regulation (EU) 2017/745 on medical devices (MDs) an
21/07/2020
Medical devices: management of hazardous substances during the transition to regulation (EU) 2017/745
Protecting human health and the environment from the risks that chemicals can pose has always been a priority for Europe. In 2007,
25/06/2020
What is the scope of IEC62304?
With changes in new technologies and the need to digitise our environments, more and more medical devices (MDs) are integrating or
28/04/2020
Masks: how to access the french market
Gaining access to the European market depends on the type of mask you wish to market. Below we set out the various types of masks,
7/04/2020
Placing on the market of biocidal products
What is a biocidal product?According to the official definition, a biocidal product is:Source : Règlement (UE) N°528/20
20/02/2020
Validation of analytical procedures according to the ICH guidelines
Since 1990, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) has been