Blogs

The Central Drugs Standard Control Organisation (CDSCO) has released extensive draft guidance for medical device software under the Medical Devices Rules (MDR), 2017. This move aims to harmonise India’s device-software oversight with global standards, bringing...

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...