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 ...

A medical device manufacturer ditched a clunky ERP module for quality inspection, opting instead for specialized statistical process control software. Upgrading to new software costs time and money ...

Successful implementation requires modern healthcare infrastructure, including reliable electricity, high-speed internet ...

It takes months of R&D, numerous prototypes, and a few scrapped concepts for the design of a device used in patient care to be finalized and approved. However, one aspect is often still missing at ...

“Classification isn’t an administrative detail; it’s the foundation of patient safety,” he says. “If a platform is being used to support clinical decision-making, issue alerts or guide escalation, ...

Editor’s note: This article is the third in a series to help practitioners learn about the AICPA’s new quality management standards and prepare to implement them. The new final standards on quality ...

Medical device manufacturing is a high-stakes game where efficiency meets precision. With tight regulations, complex designs, and a need for speed, how do companies stay ahead without cutting corners?

Aim: To demonstrate the potential of in-line nanoparticle size measurements using the NanoFlowSizer (NFS) as a PAT method. To achieve real-time process control by establishing automated regulation of ...