Technical articles
15/01/2024
Ensuring the safety of medical devices, an essential tool: risk management according to ISO 14971:2019
IntroductionMedical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD) shall be designed and manufactured to ensure thei
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
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
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?
Join our team
Consult our offers
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
