Developing a medical device is a lengthy process. Prior to commercial distribution, FDA requires that the manufacturing process for the product be validated. Process validation is defined as the ...

This paper briefly discusses the approaches for Validation Environment and Test methodologies adopted for 8-bit microcontroller family based products. We would be focusing on modularity and the need ...

Overview: Process Validation is required by FDA and most regulatory bodies. PV demonstrates consistency of pharmaceutical processes. PV requires writing and executing a validation protocol that ...

The FDA's Office of Combination Products recently finalized guidance emphasizing the critical role of human factors engineering (HFE) in the development of combination medical products. Eurofins Human ...

Palo Alto, Calif.—Test-and-measurement supplier Agilent Technologies has some measurement innovations for its existing E2960A serial protocol tester/exerciser for PCI Express. The new capabilities ...

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 ...

Few studies have been conducted on blood pressure monitors and their use at high altitude. This study is the first to evaluate the accuracy of an automatic blood pressure monitor in a high-altitude ...

DIRECTOR General, National Institute for Pharmaceutical Research & Development, NIPRD, Dr. Obi Adigwe, has said that his agency’s phytomedicines verification and validation protocol will bring about ...