CLIENT: A developer and manufacturer of component parts used in medical devices CHALLENGE: The client had an opportunity to supply component parts for an implantable device. Senior executives rejected ...

The U.S. Food and Drug Administration recently issued a draft guidance titled, “Benefit-Risk Assessment for New Drug and Biological Products,” which aims to provide a clearer understanding how a ...

Explore how DFMEA transforms product development by identifying potential risks, optimizing designs, and ensuring compliance with regulatory standards.

[Asia Economy Reporter Jeong Dong-hoon] Lotte Chemical will be the first in the domestic chemical industry to conduct risk assessments on its own manufactured products. Product risk assessment is a ...

These days we hear a lot about trust in cybersecurity. From zero trust, which demands that we “never trust and always verify,” to the implicit decentralized trust that fuels blockchain technologies, ...

Environmental contamination control is a crucial aspect of sterile pharmaceutical manufacturing, and risk management is needed to guarantee that the necessary control procedures are in place. The risk ...

According to a report from NPR, Meta plans to shift the task of assessing its products' potential harms away from human reviewers, instead leaning more heavily on AI to speed up the process. Internal ...