Technical articles
7/08/2025
MDR 2017/745 and IVDR 2017/746: What requirements for what solutions?
This article delves into these regulatory expectations and provides essential insights for navigating this reinforced framework.
24/07/2025
ECHA accelerates the transition towards animal-free chemical evaluations
The ECHA is announcing its commitment to drastically reduce, and then eliminate, animal testing.
10/07/2025
Women in Engineering Day: Amandine’s story of leadership, resilience and technical excellence
Amandine Pousse shares her inspiring engineering journey on International Women in Engineering Day.
26/06/2025
Efor takes action for cancer research with the “Get Your Sneakers On” challenge
Our employees took part in the “Get Your Sneakers On” challenge organized by the Centre Léon Bérard.
5/06/2025
Designing a PMCF Study: The Question of Sample Size with a Fictional Example
PMCF studies are key tools for meeting MDR requirements and ensuring device safety and performance.
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22/05/2025
The Impact of Presidential Executive Orders on the Pharmaceutical and Medical Devices sectors in the USA
Recent developments in United States (US) healthcare regulation have brought significant changes to the process of approving pharm
30/04/2025
Design and Development Management of a MD / IVDMD according to Standard EN ISO 13485:2016 + A11:2021
Comment garantir que chaque dispositif réponde aux performances prévues ?
10/04/2025
In-House Medical Devices: Understanding the Regulatory Framework and Compliance Requirements under European Regulations (EU) 2017/745 and 2017/746
This article explores the specific rules for so-called 'in-house' medical devices, manufactured or modified by healthcare institut
3/04/2025
International Women’s Rights Day
Looking back on our solidarity challenge for International Women's Rights Day.
13/03/2025
Indications, Intended Purpose, Claims, and Medical Device Regulation 2017/745:What Are the Differences, and What Are the Implications?
In the field of medical devices, the terms indications, claims, and intended purpose/intended use play a fundamental role in the d
27/02/2025
EN ISO 13485: 2016 / A11: 2021: The Strategic Lever to Transform Compliance into Competitiveness
ISO 13485 positions itself as an essential tool to protect patients and users while strengthening their confidence in medical devi
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
