Technical articles
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
25/12/2025
Digitalization: Transforming processes to accelerate innovation in Life Sciences
Digitalization has become a crucial strategic lever for companies in the life sciences sector. It involves transforming objects, p
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
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.
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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.
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
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
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
30/05/2024
Shared audits: a simple, cost-effective solution for suppliers, subcontractors and service providers
Suppliers, subcontractors and service providers are increasingly called upon by their customers to carry out assessment audits. Th
