Efor news & technical articles
14/11/2023
Efor accelerates the structuring of its center of excellence for health data valorization.
With a position among the leaders in specialized consulting for Life Sciences industries, the Efor Group supports its clients thro
6/11/2023
ICH Q12 application for the implementation of a change: example of a site transfer
The ICH Q12 guideline entitled « Technical and regulatory considerations for pharmaceutical product life cycle management” is
9/10/2023
Clinical evaluation according to Article 61(10) of Medical Device Regulation (EU) 2017/745
Purpose of conducting a clinical evaluationRegulation (EU) 2017/745 (article 2(44)) relating to medical devices defines clinical e
25/09/2023
Toxicological risk assessment and 2023 revision of ISO 10993-17 standard
All the answers about ISO 10993-17 and its revision
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?
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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
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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
