BIS Medical Device Testing Standards: Essential Requirements for the Indian Market
Why BIS standards matter more than ever India’s medical device industry is scaling up, and so are the regulations that […]
NABL Medical Device Testing: Integrating IEC 60601 with ISO 13485
The Role of NABL in Medical Device Testing In India, the National Accreditation Board for Testing and Calibration Laboratories (NABL)
How Astute Labs’ Dual Accreditations (BIS + NABL) Simplify Compliance for Medical Device Makers
Why dual accreditation makes compliance simpler in India If your product roadmap includes electrical medical equipment, you already juggle two
How Astute Labs Helps Manufacturers Reduce Certification Delays
Certification Delays: A Persistent Challenge for Manufacturers Delays in medical device certification are one of the biggest hurdles for manufacturers
Understanding BIS Recognition for Medical Device Testing Labs
Bureau of Indian Standards (BIS) recognition for medical device testing laboratories has become a cornerstone of India’s healthcare compliance framework.
Which Tests Does My Medical Device Need?
Medical devices must undergo rigorous testing before they can be marketed. Testing ensures safety, performance, and regulatory compliance, but the
CDSCO Approval Process for Medical Devices in India
India’s medical device market is growing fast, presenting huge opportunities for manufacturers. However, obtaining approval from the Central Drugs Standard
IEC 60601-1-2 EMC Testing: Why It’s Crucial for Medical Device Certification
Electromagnetic compatibility (EMC) is no longer just a checkbox on the path to medical device approval. In a hospital filled
Electrosurgical Analyzer Testing: Why It’s a Must for ESU Safety
Electrosurgical units (ESUs) are used in the majority of modern surgeries, offering precision cutting and coagulation using high-frequency energy. But
BIS Certification for Medical Electronics: Why and How to Get the BIS Mark
BIS certification is no longer just a regulatory formality. For manufacturers and importers of medical electronics in India, it is