Author name: Abdon Marques Cunha

U.S. medical device UDI compliance concept with barcode packaging and regulatory data dashboard

When Does a Medical Device Need UDI in the U.S.?

FDA & U.S. Regulatory / Abdon Marques Cunha

Understand when FDA UDI requirements apply to medical devices, including device identifiers, GUDID, direct marking, exceptions, and key considerations for the U.S. market.

Medical device regulatory and technical consulting concept focused on the U.S. market

Medical Device Technology

FDA vs. ANVISA: Key Differences Medical Device Manufacturers Should Know

Medical Device Technology / Abdon Marques Cunha

A practical overview of the key differences between FDA and ANVISA medical device regulation, including classification, submission pathways, quality requirements, and strategic considerations for manufacturers.