Technical articles
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
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
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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
17/10/2024
Management of user interfaces of unknown provenance (UOUP) in medical devices according to the IEC 62366-1:2015 + A1:2020 standard
With the implementation of European Regulation (EU) 2017/745, both the official texts and the authorities are placing particular e
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
2/07/2024
Medical Devices: Now Introducing the Medical Visit Charter!
The Medical Device (MD) and In Vitro Diagnostic Medical Device (IVDMD) sector is subject to increasingly stringent regulations.
16/05/2024
Regulatory and Standard Monitoring: Staying the Course Towards Compliance
Whether in the life cycle of a medical device (MD) or an in vitro diagnostic medical device (IVDMD), it is not uncommon to face un
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
15/01/2024
Ensuring the safety of medical devices, an essential tool: risk management according to ISO 14971:2019
IntroductionMedical Devices (MD) and In Vitro Diagnostic Medical Devices (IVDMD) shall be designed and manufactured to ensure thei
