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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 [...]
The FDA regulates blood and tissue products to protect public health and ensure safety, efficacy, and quality. Facilities such as blood banks, cord blood banks, and tissue establishments must comply with rigorous regulatory requirements, including registration, donor eligibility screening, labeling, and traceability documentation. At XPRO AMERICA, we provide comprehensive 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. [...]