Achieving U.S. FDA compliance is only the first step maintaining it requires constant attention. FDA regulations are dynamic, with frequent updates to labeling rules, safety standards, registration requirements, and inspection…
Medical Device Reporting (MDR) under 21 CFR Part 803 requires manufacturers, importers, and device user facilities to report adverse events and product problems to the FDA. Compliance with MDR regulations…
For companies regulated by the U.S. Food and Drug Administration (FDA), compliance is not a one-time process but an ongoing responsibility. Each year, manufacturers, distributors, importers, and other regulated entities…
Ensuring consumer safety is at the core of FDA regulations, and one of the most critical obligations for companies in the food, dietary supplement, cosmetic, and OTC product industries is…