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510(k), Clinical Trial, FDA, Medical Devices, Meditrial, Regulatory, Regulatory Affairs, USA▪October 5th, 2026▪12.4 min▪Practical 510(k) vs PMA vs De Novo FDA Pathway Guide
Practical 510(k) vs PMA vs De Novo guidance for choosing an FDA device pathway based on classification, predicates, risk, and evidence needs
Clinical Trial, Compliance, Europe, European Union, MDCG, Medical Devices, Meditrial, Regulatory, Regulatory Affairs▪September 23rd, 2026▪12.1 min▪Build a Defensible Clinical Evidence Strategy Under EU MDR
Build a defensible clinical evidence strategy under MDR Annex XIV, from the clinical evaluation plan to PMCF and notified body review.
Clinical Trial, EMA, EUDAMED, Europe, European Union, MDCG, Medical Devices, Meditrial, Regulatory, Regulatory Affairs▪September 15th, 2026▪11.1 min▪Getting a CE mark for medical devices: a step-by-step guide
Practical guidance on the CE mark for medical devices under EU MDR, from classification and evidence to conformity assessment and EUDAMED
A Practical RBQM Framework for Medical Device Trials
Risk-based quality management for medical device trials, with practical actions for risk assessment, monitoring, data review, and trial oversight
EU Breakthrough Medical Devices Under MDCG 2025-9 (BtX)
EU breakthrough medical devices gain a clearer regulatory pathway under MDCG 2025-9, with early advice and lifecycle evidence planning
What Swissmedic Fast-Track Means for Clinical Trial Sponsors
Swissmedic swissethics Fast-Track Pilot Project accelerates eligible trial reviews and makes coordinated regulatory preparation increasingly important.
The contribution of patient associations in clinical trials
Historically, patient organizations have had the primary purpose of supporting the communities they represented. Today, this remains a crucial function, [...]
The importance of the Data Monitoring Committee in the trials of today and tomorrow
Dr. Paola Antonini, Meditrial Scientific Director All clinical trials benefit from oversight, which is currently provided by regulatory [...]
