Technical articles
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
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
Join our team
Consult our offers
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
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
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
25/09/2023
Toxicological risk assessment and 2023 revision of ISO 10993-17 standard
All the answers about ISO 10993-17 and its revision
23/08/2023
Animal testing and medical devices: where do we stand?
Animals have long been used in the research phase to guarantee the safety & efficacy of pharma and DM products. What about today?
