News Efor
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?
24/07/2023
Machine Learning applied to OMICS data
Machine Learning is widely used in data science, but did you know that it can also be applied to OMICS data?
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
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
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
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
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
