Technical articles
18/06/2024
How to conduct a metagenomics project
Metagenomics, the science of genetic analysis of microbial communities, i.e., all the microorganisms (bacteria, viruses, fungi, ye
17/04/2024
Focus on AET and TSL
Among the changes introduced by the 2023 version of ISO 10993-17 (Biological evaluation of medical devices - Toxicological risk as
12/12/2023
Metagenomics
Metagenomics is a method for studying the microbiome, i.e., all the microorganisms (bacteria, viruses, fungi, yeasts, plankton, et
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
25/09/2023
Toxicological risk assessment and 2023 revision of ISO 10993-17 standard
All the answers about ISO 10993-17 and its revision
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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
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
