The EU Medical Device Regulation (MDR) is the most significant regulatory change in Europe in over 20 years. The MDR will replace the Medical Device Directive 93/42/EEC, effective 26th May 2020. The MDR entered …
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 …
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 …
