Technical articles
12/06/2025
Lifetime and Lifecycle in the Upcoming ISO 10993-1 Standard (2025): Who, When, What, and How?
Analysis of the life cycle and service life of a medical device to better anticipate the challenges of biological evaluation under
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.
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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.
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
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
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
17/10/2024
Management of user interfaces of unknown provenance (UOUP) in medical devices according to the IEC 62366-1:2015 + A1:2020 standard
With the implementation of European Regulation (EU) 2017/745, both the official texts and the authorities are placing particular e
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
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
