Efor news
19/03/2026
Reimbursement of Health Products in France: A Public-Health and Market-Access Issue
This article provides a concise overview of the reimbursement dossier journey, outlining its stakes, the key stakeholders involved
5/02/2026
Risk-Based Monitoring and the impact of ICH E6 (R3) on clinical trials
Revision 3 of the Good Clinical Practice guideline (ICH E6 [R3]) was adopted on 6 January 2025 and will take effect on 23 July 202
22/01/2026
Clinical Data Management: The Art of Managing Clinical-Trial Data
This article delves into the fundamentals of Clinical Data Management and shows why it is essential to the success of today’s sc
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
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
Join our team
Consult our offers
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.
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.
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
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
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
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
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
