Technical articles
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.
3/04/2025
International Women’s Rights Day
Looking back on our solidarity challenge for International Women's Rights Day.
27/03/2025
PFAS in Medical Devices and Pharmaceuticals: What manufacturers need to know
PFAS can be released and accumulate in the environment. They also pose risks to human health.
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
30/01/2025
Ethylene Oxide: a Widely Used but Controversial Sterilizing Agent
La stérilisation à l’oxyde d'éthylène (OE) fait partie des méthodes les plus largement utilisées pour stériliser les disp
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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
21/11/2024
Stability and transport validation of sterile medical devices
Validating the stability and transport of sterile medical devices is an essential process for ensuring the safety and efficacy of
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
27/09/2024
ISO/DIS 10993-1, A new revision underway – Analysis of the ISO 10993-1 standard revision draft
The draft of the new revision of ISO 10993-1, addressing the biological evaluation of medical devices (MD), was released at the en
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
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
