Technical articles
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,
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
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
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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
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
