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Entries by Meghan
software-as-a-medical-device

Software as a Medical Device (SaMD)

SaMD: A need for Regulatory Reform in Australia
In February 2019, the TGA issued a consultation for feedback from industry on how Software as a Medical Device (SaMD) is regulated in Australia. Currently, SaMD is …

vial-inspection

5 Things to Know About MDSAP in 2020

What is the Medical Device Single Audit Program (MDSAP)?
The Medical Device Single Audit Program (MDSAP) was launched by the International Medical Device Regulators Forum (IMDRF) in 2014 as a pilot program, satisfying the requirements …