Donawa Lifescience has launched the Donawa InTeam flexible clinical staffing service to provide medical device and IVD companies fast access to qualified clinical professionals — Clinical Project Managers, Clinical Research Associates and Clinical Study Assistants — who join the client’s team on a fixed assignment, with none of the delays typically associated with recruitment. Through Donawa…

The Australian start-up company Tournicare Pty Ltd has achieved US marketing clearance from the Food and Drug Administration (FDA) for its ARMA over-the-counter Blood Pressure Monitor (BPM) via the 510(k) pre-market notification process with regulatory assistance from Donawa Lifescience. Tournicare announced its success in a LinkedIn post in mid-June. Tournicare CEO Niels van Sparrentak explains:…

Donawa Lifescience President, Maria E. Donawa, M.D., has authored a ‘Regulatory Recap’ article on LinkedIn titled ‘Proposed MDR Amendments and Clinical Data Requirements.’ Following Dr. Donawa’s February 2025 LinkedIn article on the current MDR’s clinical data requirements, the Commission’s December 2025 proposed MDR amendments have now been reviewed with particular attention to clinical data and…