Tag Archives: ppe

New EU MDR: Who Are The “Economic Operators” For Imported Devices?

Since May 2021, the New EU MDR Medical Device Regulation 2017/745 is in place. One of its objectives has been improving the safety of users and patients. And one way to achieve that objective is ensuring that all the parties involved … Continue reading

Posted in EU MDR | Tagged , , , , , , | Leave a comment

How The EU MDR Will Change The Medical Device Industry Forever [Podcast]

Our CEO Renaud is joined again by Clive Greenwood, a China-based product compliance expert, to discuss the new EU MDR. We all heard about the Wild West of PPE imports in the early days of the pandemic where worrying amounts of substandard … Continue reading

Posted in EU MDR, Sofeast Podcast | Tagged , , , , , , , | Leave a comment

We’re Buying Medical Devices From China And Are Worried Our Supplier Isn’t Legit | Disputes With Chinese Suppliers Q&A (Volume 8)

Unfortunately, the Covid-19 pandemic is still with us here in summer 2021 and so there’s still a great interest in purchasing medical devices such as medical-grade nitrile gloves, gowns, and surgical masks from China for use in hospitals and other … Continue reading

Posted in Disputes with Chinese suppliers | Tagged , , , , , , | Leave a comment