Technical articles
31/10/2024
Medical and scientific communication: disseminating knowledge for the benefit of patients and practitioners
Manufacturers use ever-more-innovative technology to provide items at the forefront of medical research, contributing to the desig
12/09/2024
Quality Management System Regulation (QMSR), the FDA’s new regulation applicable to medical devices: We explain it all!
The QMSR, published by the FDA, imposes new requirements on medical device manufacturers. Discover the key changes to comply with
7/08/2024
Importance and design of PMCF studies for medical devices in Europe: framework and principles
Medical Device Regulation (MDR) 2017/745, which has been enforced since May 26, 2021, has significantly reinforced the regulatory
5/03/2024
Literature review: a key element in DM development
The design of a medical device is a complex stage, requiring in-depth knowledge of available technologies, unmet clinical needs, e
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
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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
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
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
