Efor news & technical articles
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
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
12/11/2020
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
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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
17/05/2020
Hospital Information Systems (HIS): context, challenges, and opportunities in healthcare data
Healthcare institutions generate and store a vast amount of data. From the moment a patient enters a facility, they provide a sign
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
4/02/2020
New trends in medical journals: limited use of p-values in favour of estimated indicators and confidence intervals
Why is the p-value, once so widely used, now being called into question?
