Under the MDR, clinical evaluation must include an appraisal of clinical data to determine whether the evidence is suitable for establishing a device’s safety and performance. If the data are insufficient, CE marking can be delayed or put at risk. Methodological quality and scientific validity are central to that appraisal. Manufacturers need to understand how…

Running a medical device or IVD clinical study involves dozens of activities across three phases: preparation, enrolment, and close-out. A team carries out the work, but someone has to know what must happen, when, and who is responsible. That is clinical project management, and it is the part of a study less experienced Study Sponsors...

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…

      Donawa Lifescience congratulates PainChek Ltd on receiving United States (US) Food and Drug Administration (FDA) De Novo clearance for its PainChek® Adult Intelligent Pain Assessment App (DEN240073). This groundbreaking app is the world’s first smart device-based medical device for pain assessment, designed for individuals who are unable to reliably verbalize their pain….