On September 13, 2022 the Center for Devices and Radiological Health (CDRH) and the Center for Biologics Evaluation and Research (CBER) jointly released a new draft guidance document titled “Computer ...

Korrapati's implementation work is complemented by industry engagement, including presenting on CSA implementation and roadblocks at professional venues ...

Ketryx Corp., a startup that offers connected application lifecycle management software that’s tailor-made for the life sciences and medical industries, said today it has closed on a $14 million early ...

The advent of artificial intelligence (AI) and data-driven methodologies has triggered a wave of transformation in regulatory compliance and quality assurance for the development of medical devices.

We missed this earlier: On October 21, the Central Drugs Standard Control Organisation (CDSCO), under the Ministry of Health and Family Welfare (MoHFW), released draft guidelines for granting licences ...