Author name: Astute Labs

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

BIS certification is no longer just a regulatory formality. For manufacturers and importers of medical electronics in India, it is

In modern healthcare, precision in drug delivery is no longer a luxury; it’s a necessity. Devices like infusion pumps and

Infant incubators are essential in neonatal care, providing premature infants with the controlled environment they need to survive and thrive.

Anaesthetic workstations play a critical role in healthcare settings, supporting safe and efficient anaesthesia delivery during surgeries and critical care