Author name: Astute Labs

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

Life-support devices such as ventilators and defibrillators play a critical role in emergency and ICU settings. In India, these devices

Indian medical device manufacturers are entering a pivotal regulatory transition as BIS formally adopts IEC 60601-1:2020 under IS 13450:2024. This

Why BIS standards matter more than ever India’s medical device industry is scaling up, and so are the regulations that

The Role of NABL in Medical Device Testing In India, the National Accreditation Board for Testing and Calibration Laboratories (NABL)

Why dual accreditation makes compliance simpler in India If your product roadmap includes electrical medical equipment, you already juggle two