Author name: Astute Labs

Why Class B vs Class C is not just a classification label Under India’s Medical Devices Rules, 2017, the distinction […]

Why battery-operated medical devices face dual compliance Battery power has moved critical functions beyond controlled hospital environments into ambulatory, home-care,

Alarm integrity is an essential performance, not an accessory In critical care environments such as ICUs, alarm systems are not

Medical electrical devices rarely remain unchanged after launch. Component availability shifts, suppliers change, PCB layouts are refined, power modules get

The Bureau of Indian Standards plays a central role in maintaining safety and performance benchmarks for medical devices in India.

Testing medical devices in a BIS-recognized laboratory is essential for manufacturers and importers seeking market access in India. BIS testing

Independent medical device testing is central to ensuring regulatory confidence. Regulators expect objective proof that a device is safe, reliable,

Testing is a mandatory requirement for medical devices manufactured or imported into India under the Medical Device Rules 2017. A

Every month of delay costs a medical device manufacturer time, money, and market share. Many of these delays come from