Category Archives: Whitepaper

Team-NB Position Paper

This position paper includes a definition of ‘systemic off-label use’ (device used repeatedly or continuously outside [...]

Whitepaper: Surveys as a method of PMCF

Post-Market Clinical Follow-up (PMCF) is the continuous process of pro-active clinical data collection of a [...]

Monitoring in Medical Device studies: what is needed?

If you are a manufacturer who started a clinical trial, then you have the obligation [...]

Fifteen most-frequently asked questions on Clinical Evaluation for Europe

One of the significant changes in EU regulatory science for medical devices is the enhanced [...]