Labeling & IFU Review
Documentation a clinician can actually follow.
Labels and instructions for use are where regulatory language meets the person holding the device at 3 a.m. Reviewed only as a compliance exercise, they may pass inspection and still fail in the ward.
AVRA reviews labeling and IFUs against three questions at once: does the content meet the applicable requirement, does it match the device’s actual intended use, and does it work for the clinician in the environment where the device is used?
AVRA supports
- IFU technical review against intended use and stated indications
- Labeling review for regulatory content, symbols, and traceability elements
- Consistency across labeling, IFU, technical file, and marketing claims
- Portuguese-language adaptation for the Brazilian market
- Clinical-workflow review of instructions and labeling as risk controls
- Service manual and technical-documentation review
Experience behind the service
Routine labeling and IFU preparation and review across a 44-registration portfolio, supported by 25+ years observing how devices are operated, maintained, and misused in hospital environments — including ICU, pediatric high-acuity, and infectious-disease settings.