• Healthcare solutions from SaMD resources

    27 July 2020 SaMD
    With the new generation of medical devices, the software content in the devices is ever ...
  • Why Resilience is more important now?

    20 July 2020 LCM
    In the midst of the Covid-19 crisis, we have become painfully aware of the fragility of supply ...
  • Medical Devices – Regulatory Updates – July Volume 2

    16 July 2020 Regulatory Updates
    Europe | US FDA | Canada (HC) | Australia (TGA) | Hong Kong (Medical Device Division) | ...
  • Medical Devices – Regulatory Updates – July Volume 1

    2 July 2020 Regulatory Updates
    Europe | Australia ( TGA ) | Malaysia (MDA) | Pakistan (DRAP) | Singapore ( HAS ...
  • Medical Devices – Regulatory Updates – June Volume 2

    17 June 2020 Regulatory Updates
    1.MDCG issues guidance on transitioning devices with ancillary substances to MDR The European ...
  • Medical Devices – Regulatory Updates – June Volume 1

    3 June 2020 Regulatory Updates
    1.The AEMPS extends the deadline until May 25, 2021 for the adequacy of the labeling and the ...
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