Technical articles
16/04/2026
Design Transfer according to ISO 13485:2016: From Development to Medical-Device Production
Design and development, which culminate in design transfer, are pivotal stages in the life cycle of a medical device.
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
5/03/2026
The Talc Debate: Health Risks and Controversies
A seemingly harmless natural mineral, talc has once again become the focus of a major public-health debate in 2025
19/02/2026
Post-Marketing Authorisation Variations: The changing European regulatory landscape, from regulation to guidance
As of 15 January 2026, the European framework for managing post-marketing authorisation (MA) variations for human medicinal produc
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
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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
8/01/2026
Behind every Smart AI is smarter Data Management
Artificial Intelligence (AI) is reshaping industries, influencing decisions from medicine to transportation, finance to entertainm
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.
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
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
