Software IN versus AS a Medical Device
The healthcare industry has always relied on new t...
Understanding UDI Requirements for Medical Devices: A Comprehensive Guide
The Unique Device Identification (UDI) system is a...
Software as Medical Device: Agile Alignment with GAMP5 Validation
The GAMP 5 framework/five-phase approach (Refer Fi...
ANVISA New Medical Device Regulation RDC 751/2022
On March 1st, 2023, the new RDC (Resolution of the...
