Technical articles
30/04/2026
Major Evolutions of EU GMP Chapters 1 and 4: Towards a Reinforced Governance of Quality, Data, and Knowledge
European regulatory authorities have initiated a revision of Chapter 1 (Pharmaceutical Quality System) and Chapter 4 (Documentatio
5/03/2026
The Talc Debate: Health Risks and Controversies
A seemingly harmless natural mineral, talc has once again become the focus of a major public-health debate in 2025
8/01/2026
Behind every Smart AI is smarter Data Management
Artificial Intelligence (AI) is reshaping industries, influencing decisions from medicine to transportation, finance to entertainm
6/11/2025
Thresholds of Toxicological Concern (TTC)
The toxicological risk assessment of a device’s constituents (ISO 10993-17) relies on data obtained either through chemical char
23/10/2025
IT Infrastructure Qualification: Better Risk Management Due to Regulatory Requirements
The qualification process—covering IQ, OQ, and PQ—takes a structured and thorough approach to validating technical components
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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.
3/07/2025
Unlocking the Potential of Comparative Genomics in Bacterial Research
This article explores the key steps and methodologies in bacterial comparative genomics.
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
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
19/12/2024
The use of artificial intelligence in omics to predict patient survival
In recent years, artificial intelligence (AI) has been a highly publicized field due to its transformative impact on society. AI i
