Technical articles
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.
3/04/2025
International Women’s Rights Day
Looking back on our solidarity challenge for International Women's Rights Day.
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
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
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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
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
12/09/2024
Quality Management System Regulation (QMSR), the FDA’s new regulation applicable to medical devices: We explain it all!
The QMSR, published by the FDA, imposes new requirements on medical device manufacturers. Discover the key changes to comply with
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
