Month: February 2018

Are-you-up-to-date-with-the-rapidly-changing-reimbursement-environment-Brandwood-Biomedical

Are you up to date with the rapidly changing reimbursement environment?

There is likely to be a lot of activity in the Private Health Sector in Australia in 2018, particularly in medical devices. Following on from the highly publicised five-year Prostheses...
Using-Chinas-Innovative-Device-Pathway-CFDAs-Yongheng-Chang-to-address-Asia-Pacific-Device-Summit-Brandwood-Biomedical

Using China’s Innovative Device Pathway; CFDA’s Yongheng Chang to address Asia Pacific Device Summit

We are delighted to confirm that the forthcoming Asia Pacific Device Summit will feature a presentation by Yongheng Chang of China Food and Drug Administration. Mr Chang will speak on...
How much clinical data for established devices Brandwood Biomedical

How much clinical data for established devices?

The new European MDR and IVDR require that all devices are re-qualified.  There is no provision for grandfathering - everyone has to start from the beginning. This can be a...
TGA introduces priority review pathway Brandwood Biomedical

TGA introduces priority review pathway

As we introduce a new year, we’ve hit the ground running with new guidance documents published by the Australian regulatory (Therapeutic Goods Administration) in early January. The guidance outlines the...
I've a great idea but now what Brandwood Biomedical

I’ve a great idea, but now what?

After attending the Medtech Monday event held in Irvine this week, it became very apparent that the thought of managing the regulatory or quality requirements of your product was a...

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