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AI Act, GDPR, and Medical Devices: When Regulations Collide
How to anticipate the overlap between the AI Act, GDPR, and MDR in HealthTech—and turn complexity into a strategic advantage.
Artificial IntelligenceGDPR10/28/2025
SaMD: Designing, Certifying, and Evolving Your Software
Practical guide to designing, certifying, and evolving medical device software in compliance with the MDR
SaMDMDRCertification7/10/2025
MDR Technical Documentation: Requirements and Practical Obstacles
Analysis of notified body expectations and common blocking points in MDR technical files
Technical documentationCertificationNotified bodies6/24/2025
Simplify the classification of your medical devices with our new widget!
Presentation of the new DM classification widget
Company News6/19/2025
What's EUDAMED like in 2025?
State of play of EUDAMED in 2025: available modules, key deadlines and upcoming obligations for stakeholders in the medical sector
Regulatory6/17/2025
ISO 13485 vs MDR: complementarity or complexity ?
Understanding how ISO 13485 and MDR complement each other to better structure medical device compliance without getting lost in regulatory complexity
RegulatoryQuality Management Systems6/13/2025
UDI & Class I Medical Devices: The obligation is now in effect. Are you ready?
Since May 26, 2025, UDI labeling has been mandatory for Class I medical devices, a regulatory requirement that profoundly transforms manufacturers' operations.
Regulatory news6/10/2025
Update of the Manufacturer Incident Report (MIR) form
Explanation of what's new in the updated MIR form
Regulatory news6/5/2025
The role of notified bodies
The importance of choosing a notified body for the conformity of a medical device
RegulationsNotified bodies5/29/2025
What is a medical device?
Definition of a medical device
Regulations5/27/2025
Certeafiles is Qualiopi Certified: A Mark of Quality
Certeafiles has obtained the Qualiopi certification
Company NewsTrainingCertification5/19/2025