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.
FDA Breakthrough Device Acceleration
How innovative MedTech companies can accelerate FDA approval, secure Medicare coverage, and reach patients faster—starting with Breakthrough Device Designation.
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, but modes have changed, as has the role that associations and patients themselves take on in clinical research. The WHO [...]
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 authorities, Ethics Committees or Institutional Review Boards, and Data Monitoring Committees (Dmc), also sometimes referred to as Data Safety Monitoring [...]
Early feasibility studies on devices: “doing it sooner” to avoid trial failure
Paola Antonini, Meditrial Scientific Director. It is estimated that more than 90% of clinical trials fail due to limited patient recruitment, investigator inefficiencies, insufficient understanding of local ethical and regulatory aspects, site and region selected for conducting the [...]
SaMD, artificial intelligence and machine learning: regulators’ first steps
Dr.ssa Paola Antonini, Meditrial scientific director The International medical device regulators forum (Imdrf), describes Software as a Medical Device (SaMD) as software that can run on generic (non-medical) computing platforms. They can be used in conjunction with other [...]
Clinical trials, how biomarkers help research
Dr.ssa Paola Antonini, Meditrial scientific director In recent years, the field of biomarkers in research and clinical practice has shown remarkable progress. These tests can be used in the screening, diagnosis, characterization, and monitoring of diseases; as prognostic [...]
