Author name: Astute Labs

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

Certification Delays: A Persistent Challenge for Manufacturers Delays in medical device certification are one of the biggest hurdles for manufacturers

Bureau of Indian Standards (BIS) recognition for medical device testing laboratories has become a cornerstone of India’s healthcare compliance framework.

Medical devices must undergo rigorous testing before they can be marketed. Testing ensures safety, performance, and regulatory compliance, but the

India’s medical device market is growing fast, presenting huge opportunities for manufacturers. However, obtaining approval from the Central Drugs Standard

Electromagnetic compatibility (EMC) is no longer just a checkbox on the path to medical device approval. In a hospital filled

Electrosurgical units (ESUs) are used in the majority of modern surgeries, offering precision cutting and coagulation using high-frequency energy. But