Technical articles
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
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
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
