Process validation is crucial for ensuring the quality of final products and the safety of these processes for manufacturing personnel and consumers in the pharmaceutical, medical device, and ...

Inadequate process validation is one of the most common issues leading to warnings from the US Food and Drug Administration (FDA). It may also be the most difficult to address, according to Max ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations.” The draft guidance ...

The US Food and Drug Administration (FDA) recently issued its draft guidance, Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations ...

Medical device manufacturers developing digital health products face a recurring question: Will the U.S. Food and Drug Administration (FDA) regulate this product? Many digital health products can ...

Inadequate process validation related to medical devices was cited more than 600 times by the US Food and Drug Administration (FDA) in 2013. In efforts to meet the agency’s standards, device ...

In biopharmaceutical manufacturing, consistency is vital but hard to achieve. Turning raw materials into safe, high-quality medicines requires stable processes. However, the living cellular expression ...

Artificial intelligence (AI) has practically limitless applications in healthcare, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...

Ethics Committee Approval Received for Pivotal Study Intended to Support U.S. FDA Class II Submission for QuickScan™ Strep A VANCOUVER, BC, June 4, 2026 /CNW/ - Light AI Inc. ("Light AI" or the ...

Artificial intelligence (AI) has practically limitless applications in health care, ranging from auto-drafting patient messages in MyChart to optimizing organ transplantation and improving tumor ...