Blogs

Introduction Before a medical device ever touches a patient’s life, its safety, accuracy, and performance must be proven beyond question. This critical assurance begins not at the manufacturing line, but within the design verification process...

Introduction In September 2025, the U.S. Food and Drug Administration (FDA) finalised guidance detailing how it will authorise in vitro diagnostic (IVD) tests under emergency conditions. This move responds to longstanding calls for clarity in...

Overview The International Medical Device Regulators Forum (IMDRF) continues its mission to harmonise and strengthen global medical device regulations. By accelerating international regulatory convergence, IMDRF aims to build a more efficient, effective, and responsive global...