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 ...

Modular Medical (Nasdaq:MODD) announced that it started the production of validation lots for its Pivot tubeless insulin patch pump.

CTP Portal Next Generation also accepts Substantial Equivalence submissions. Step-by-step instructions on completing the forms; A more user-friendly interface that helps guide applicants through the ...

Validating drug production processes need not be a headache, according to AI researchers who say machine learning (ML) could be a single answer to biopharma’s multivariate problem. The FDA defines ...

InstantGMP categorizes software functions into low, moderate, and high process-risk groups. Low-risk features, such as equipment, room, deviation, and CAPA logs, primarily collect or tabulate data.

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

Medical device equipment manufacturers work in an environment where product quality isn't just a competitive advantage, it's a regulatory necessity with direct implications for patient safety. As ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

According to the Food and Drug Administration (FDA), the traditional paradigm of medical device regulation was not designed for adaptive artificial intelligence and machine learning technologies. As a ...

FREMONT, Calif.--(BUSINESS WIRE)--Tivic Health® Systems, Inc. (Nasdaq: TIVC), a diversified therapeutics company, announced today it has entered a definitive agreement with Scorpius BioManufacturing ...