Efor news
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
Join our team
Consult our offers
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.
22/05/2025
The Impact of Presidential Executive Orders on the Pharmaceutical and Medical Devices sectors in the USA
Recent developments in United States (US) healthcare regulation have brought significant changes to the process of approving pharm
30/04/2025
Design and Development Management of a MD / IVDMD according to Standard EN ISO 13485:2016 + A11:2021
Comment garantir que chaque dispositif réponde aux performances prévues ?
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.
13/03/2025
Indications, Intended Purpose, Claims, and Medical Device Regulation 2017/745:What Are the Differences, and What Are the Implications?
In the field of medical devices, the terms indications, claims, and intended purpose/intended use play a fundamental role in the d
