Technical articles
23/08/2023
Animal testing and medical devices: where do we stand?
Animals have long been used in the research phase to guarantee the safety & efficacy of pharma and DM products. What about today?
20/06/2023
Biocompatibility assessment of MD (ISO/TR 10993-55:2023)
Assessing the biocompatibility of medical devices is of major importance as it ensures the biological safety of products with rega
17/05/2023
Impact of a logarithmic transformation of the response variable in an ANCOVA model
Logarithmic transformations of variables have traditionally been used to study analytical measurements in clinical and industrial
27/04/2023
Clinical evaluation of medical devices
The Council Directive 93/42/EEC was the standard applicable since 1993 for all medical device manufacturers. In 2017, the European
14/03/2023
Biased estimators: focus on dispersion indicators
One of the aims of a statistical study is to estimate quantities (e.g., mean, variance, standard deviation, etc.) that can be used
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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
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
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,
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
