Blogs

In the world of medical device development, design verification and risk management are inseparable pillars of product safety. While design verification proves the device meets its design requirements, risk management ensures that it performs safely...

The Central Drugs Standard Control Organisation (CDSCO) has released extensive draft guidance for medical device software under the Medical Devices Rules (MDR), 2017.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...