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September 21, 2022

What the Medical Device Manufacturers need to know about FDA’s UDI requirements?

All the medical device manufacturers that intend to place their devices in the US should label their devices considering the Unique Device Identifier (UDI) requirements. UDI is a uniqu...

June 3, 2021

Software Precertification Program: An Innovative Approach to Expedite Patient Access for SaMD

The Software Precertification (Pre-Cert) Program is a pathway that comprises a regulatory model which is more visible than the current model to assess the safety and effectiveness, without inhib...