Technical articles
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
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.
20/03/2025
The Hospital Information System (HIS): At the Heart of the Digital Health Revolution
Hospital Information Systems revolutionize healthcare by centralizing data, optimizing care, and fostering medical innovation.
20/02/2025
Predictive Maintenance: Beyond All-AI, A Gradual Approach to Industry 4.0
In modern industry, maintenance has become a strategic element ensuring companies’ competitiveness and operational efficienc
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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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
2/07/2024
Medical Devices: Now Introducing the Medical Visit Charter!
The Medical Device (MD) and In Vitro Diagnostic Medical Device (IVDMD) sector is subject to increasingly stringent regulations.
16/05/2024
Regulatory and Standard Monitoring: Staying the Course Towards Compliance
Whether in the life cycle of a medical device (MD) or an in vitro diagnostic medical device (IVDMD), it is not uncommon to face un
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
15/01/2024
Ensuring the safety of medical devices, an essential tool: risk management according to ISO 14971:2019
IntroductionMedical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD) shall be designed and manufactured to ensure thei
