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Tag Archives: medical devices
Can you develop a new product, THEN make it comply to the requirements related to medical devices?
Let’s say that you’re an entrepreneur or business that has designed a new product that has a healthcare application and you want it to be compliant with some common medical requirements (this would seem to make sense due to the … Continue reading
EU MDR Update: How To Get a New Medical Device Certified? [Flow Charts]
If you are developing a new medical device for sale in the EU, the EU MDR update affects you as you must now get it certified to the EU MDR regulation. But what is the path to get it certified? … Continue reading
Posted in EU MDR
Tagged medical device classes, ce mark, importing into the eu, eu mdr, medical devices, medical supplies
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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 importing into the eu, eu mdr, medical devices, compliance, product compliance, importing from china, ppe
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EU MDR Changes: Are You Selling a Medical Device, and What Class Is It?
If you make, import, or distribute products that end up on the European Union market, and if your products may be categorised as medical, you need to be very clear about that. As we discussed recently, the companies involved in … Continue reading
Posted in EU MDR
Tagged medical device classes, ce mark, importing into the eu, eu mdr, medical devices, product compliance, product safety
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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 eu mdr, medical devices, compliance, product compliance, product safety, sourcing ppe, importing from china, ppe
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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
