For complex medical device systems, teams must define what must happen across subsystem boundaries, assign responsibility for ...

On Sept. 16, 2026, ISO published the sixth edition of ISO 9001. Most medical device professionals shrugged, feeling that we ...

In any Raman system, the filter that blocks the laser line shapes the quality of your results. It determines how close to the laser you can measure, how much interference gets through, and how cleanly ...

For the better part of a decade, the default advice handed to medtech founders planning a first-in-human (FIH) study fit in three words: go to Australia. The pitch was seductive and, for a while, ...

PFAS exposure for device manufacturers no longer hinges on a single rule or a single material. FDA has drawn a firmer line around fluoropolymers, yet state reporting requirements, a still-evolving EU ...

For OEMs building medical devices, diagnostic platforms, and medical instruments, precision is the baseline, not a bonus. Small variations in fluid flow, pressure, optical transmission, or component ...

IDEX Health & Science’s tubing configurator simplifies the process of specifying custom tubing assemblies for precision fluid handling applications. The tool allows users to define assembly ...

Enrolling a large number of healthy travelers into a fixed-budget study without sites puts two pressures on the operation: the volume of lead handoffs and the interest that fades while a pre-qualified ...

A clean GLP audit or a smooth pre-IND interaction feels like proof of control, yet companies that pass inspections still hit submission delays and longer diligence cycles as programs advance. The ...

AI-assisted drafting of CAPAs, deviation write-ups, and regulatory correspondence is probably already happening on your quality team, with no policy and no record. This paper argues the exposure is ...

Familiarity can make manual quality systems look sturdier than they are. Spreadsheets, shared drives, and siloed eQMS platforms may feel dependable until an inspector starts tracing a document history ...

A clean audit does not necessarily mean a medical device company is prepared for its next submission, product launch, or acquisition. Teams may pass audits consistently while still reconstructing ...