Services
Classification and gap assessment
Determining the safety class and testing what you have against what is required.
Classification and gap assessment
The starting point of every project. We assign the device to one of the four safety classes under Resolution 738 based on intended use, duration of contact, invasiveness and, for in-vitro diagnostics, the consequence of an incorrect result, and we document the reasoning so it can be defended in review. The gap assessment then compares your existing file against the Uzbek requirements for that class and for the route you intend to use, and returns a written list of missing documents, tests, translations and signatures with an estimate of effort for each. Small enough to run before a market-entry decision is taken.