FDA adverse event reporting

XPRO America – USFDA Registration Services Now Available on Fiverr & Upwork

With the rising global demand for U.S. FDA compliance, XPRO America an established provider of USFDA registration and regulatory consulting has taken a bold step forward by launching its services on top freelance platforms: Fiverr and Upwork. Traditionally operating through its website consultancy model, XPRO America specializes in guiding international [...]

FDA Clearance & Post-Market Setup Services – XPRO AMERICA

After successfully navigating the 510(k) or De Novo submission process, medical device manufacturers must secure their FDA clearance certificate and ensure ongoing compliance with post-market requirements. Timely clearance and accurate post-market setup are essential for legal distribution and long-term regulatory success in the U.S. market. At XPRO AMERICA, we provide [...]

Veterinary Medical Device Registration & Compliance – XPRO AMERICA

Veterinary medical devices are regulated similarly to human medical devices, with the FDA providing guidance to ensure safety, efficacy, and regulatory compliance for animal health products. Manufacturers, importers, and distributors must comply with device registration, product listing, labeling, and safety reporting requirements to legally market veterinary devices in the United [...]

Medical Device Reporting & Complaint Handling – XPRO AMERICA

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 ensures patient safety, reduces liability, and supports timely FDA oversight. At XPRO AMERICA, we provide end-to-end support for implementing a [...]

XPRO America – FDA Post-Market Reporting & Pharmacovigilance Support

Pharmaceutical companies must ensure the safety and effectiveness of their products even after FDA approval and U.S. market entry. This ongoing responsibility is managed through post-market reporting and pharmacovigilance programs, which play a critical role in identifying, assessing, and mitigating potential risks associated with human and veterinary drugs. The U.S. [...]

FDA Adverse Event & Safety Reporting Compliance Services – XPRO America

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 adverse event and safety reporting. The FDA requires manufacturers, packers, distributors, and importers to maintain systems for documenting and reporting [...]

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