Technical articles
28/11/2024
CDISC: Towards successful clinical trials!
In clinical research, data management and analysis are of fundamental importance in guaranteeing the validity and reliability of r
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
30/05/2024
Shared audits: a simple, cost-effective solution for suppliers, subcontractors and service providers
Suppliers, subcontractors and service providers are increasingly called upon by their customers to carry out assessment audits. Th
Join our team
Consult our offers
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
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
