FDA Compliance
At Dozuki, our teams are constantly on the factory floor. We spend hundreds of hours every year walking production lines, sitting in breakrooms with operators, and standing alongside quality managers during high-stakes audits. These site visits have given us a front-row seat to the friction…
‘This product isn’t approved to be imported into this market,” says a customs official while reviewing the importation documentation.
Local quality and regulatory teams are quickly brought into the conversation and see that the product’s registration has been valid for several…
AI adoption in medical practices is growing steadily, with most providers seeing positive ROI. But progress depends on overcoming integration, skills, and trust barriers to focus AI where it delivers real clinical and operational support.
As the healthcare industry continues to…
For decades, the process industries have relied on layers of protection to prevent hazardous events. When risk reduction requirements were high, safety instrumented systems (SIS), governed by standards such as IEC/ISA 61511, provided a clear framework for design, operation, and life-cycle…
Validating AI software makes most quality teams uneasy.
Their unease is not unjustified. The new Annex 22 provides a framework for AI use, but the guidance remains in draft. Most quality teams still have questions, especially around validation.
Why? Quality teams are…
Octave, a new company from Hexagon, is one of the latest additions in a string of improvements and innovations. This company will unite several Hexagon departments and functions, increase the efficiency of Hexagon’s digital communication, and provide support for vital infrastructure. Vick…