Efor news
13/11/2025
U.S. Government Shutdown: Consequences for manufacturers and strategic mitigation measures
The U.S. government shutdown has forced multiple federal agencies, including the FDA, to operate with limited resources.
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
9/10/2025
Understanding and mastering the differences between clinical evaluation and clinical investigation of medical devices
The distinction between clinical investigations and clinical evaluations is crucial, yet the two terms are still too often confuse
25/09/2025
The evolution of the european regulatory framework regarding electronic instructions for use (EIFU) of medical devices: analysis of regulation (EU) 2025/1234 amending regulation (EU) 2021/2226
Since the adoption of Regulation (EU) 2017/745 on Medical Devices, the European Commission has embarked on a modernization effort
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11/09/2025
CLP, REACH and PPWR: Toward Strategic Regulatory Convergence to Support Sustainable Innovation in Life Sciences
The European Union (EU) is undergoing a major overhaul of its strategy on chemical safety, product traceability and environmental
28/08/2025
FDA’s 2025 regulatory shift: integrating sex-specific data across the medical device lifecycle
In 2025, the FDA is enforcing a regulatory revolution: integrating sex-specific differences at every stage of the medical device l
7/08/2025
MDR 2017/745 and IVDR 2017/746: What requirements for what solutions?
This article delves into these regulatory expectations and provides essential insights for navigating this reinforced framework.
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
5/06/2025
Designing a PMCF Study: The Question of Sample Size with a Fictional Example
PMCF studies are key tools for meeting MDR requirements and ensuring device safety and performance.
