Why Resilience is more important now?
In the midst of the Covid-19 crisis, we have become painfully awar...
Medical Devices – Regulatory Updates – July Volume 2
Europe | US FDA | Canada (HC) | Australia (TGA) | Hong Kong (Medic...
Medical Devices – Regulatory Updates – July Volume 1
Europe | Australia ( TGA ) | Malaysia (MDA) | Pakistan (DRAP) | Si...
Medical Devices – Regulatory Updates – June Volume 2
1.MDCG issues guidance on transitioning devices with ancillary sub...
Medical Devices – Regulatory Updates – June Volume 1
1.The AEMPS extends the deadline until May 25, 2021 for the adequa...
IVD Clinical Performance Studies for FDA & EU
At present, the regulatory discussion pretty much focuses on MDR R...
