FDA Compliance
Here’s something nobody saw coming: The generation most skeptical of AI isn’t the one that doesn’t understand it. It’s the one that understands it best.
Every new technology faces resistance. The internet? A fad. Smartphones? Unnecessary. Social media? A waste of time. But tech…
In the evenings, after patients have left for the day, our research team visits the radiation oncology offices at the University of Colorado Anschutz Medical Campus to talk to medical physicists about how our research can help cancer patients. We also run experiments in their radiation suites.…
At the corner of quality and assembly, design engineers are frequently confronted with unexpected, complex fluid process issues in the prototyping phase. These obstacles are reflected in voice-of-customer sprints and surveys revealing that medical devices companies in particular stall out in the…
In 2021, container ships idled for weeks outside the Port of Los Angeles, a stark visual reminder of just how fragile modern supply-chain reliability had become. The backlog sent shockwaves across industries. Factories stalled, shelves emptied, and businesses scrambled for alternatives. It was a…
The quality systems most medtech teams are stuck with aren’t built for how they work today. 21 CFR Part 820 was authorized by the Federal Food, Drug, and Cosmetic Act of 1978, long before the software industry even existed. And while the regulations themselves aren’t going anywhere, the world…
Implementing a new quality management system (QMS) is no small task, especially for life science companies faced with stringent regulatory requirements and a high validation burden. Entrenched legacy systems compound the problem as organizational inertia and complacency lead companies to make do…