FDA Compliance
Midtier life sciences companies are spending more than ever on quality and regulatory technology, yet many are paying enterprise prices for capability they never use. The right question isn’t whether to invest in a quality management system (QMS) or regulatory information management (RIM)…
Teams building software as a medical device (SaMD) tend to think of ISO 14971 as the hardware team’s problem. Risk management files, FMEA tables, severity scores: all quality and regulatory territory, while the engineers close Jira tickets. That split is where things go wrong.
ISO…
As we celebrate the United States’ 250th anniversary this year, NIST experts have been working to preserve our nation’s history for the next 250-plus years. Among other historic preservation efforts, NIST engineers and scientists created a bespoke time capsule with artifacts from around the…
As a significant portion of the experienced manufacturing workforce approaches retirement, companies face the critical threat of losing undocumented tribal knowledge. Veteran operators possess decades of hard-won, job-specific insights that rarely exist in paper manuals or corporate file systems…
For years, many medical device manufacturers approached U.S. Food and Drug Administration (FDA) inspections through a familiar lens: Prepare documents, review subsystem requirements, rehearse likely questions, and demonstrate compliance against a known framework. That approach was shaped by the…
With Hexagon Manufacturing Intelligence’s recent announcement of its inclusion in the NASCAR Competition Partner Program, details on the strategic partnership have emerged. By cementing this tie, the two companies can expand a professional relationship that will enable them to focus on precision…