The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication
Posts published in August 2019
The Psychology of Prediction
Consideration of Uncertainty in Making Benefit-Risk Determinations in Medical Device Premarket Approvals, De Novo Classifications, and Humanitarian Device Exemptions
Meeting minutes – Competent Authorities on Substances of Human Origin Expert Group Comments about medical devices under 3.4. New Medical Device Regulation: interaction with TC…
Operating System Vulnerabilities in Many Medical Devices, Germany’s BfArM and Device Firms Warn
Medical device incident reporting (MDIR) guide
Danish Regulators Seek to Help Smaller Companies With EU MDR Compliance
Assistive technology: definition and safe use
CDRH’s Regulatory Science Priorities
As reported previously, the Notified Body IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A., designated by the Italian MOH, was included in Nando, confirming the…