Yervant Chijian

Software

EU Software Classification under MDR/IVDR – New Guidance Document

In October 2019 the Medical Device Coordination Group (MDCG) released a new guidance document on Qualification and Classification of Software in the European Regulations 2017/745 – MDR and 2017/746 –...
Cyber security copy

Cybersecurity – Is Your Device Software Secure?

In July 2019 the Australian Therapeutic Goods Administration (TGA) recently released their Medical device cybersecurity guidance for industry. This is the first guidance from the TGA on this topic which...

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