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RE:Device clearance in the EU
Posted: 5/22/2013 10:16:02 AM
From : Discussion Post>>Regulatory Open Forum
If you are planning to sell products in Europe I will assume that you must be certified to ISO 13485 or will soon be seeking this certification. (This is technically not a requirement, but practically speaking is the simplest route.) The re...

RE:Device clearance in the EU
Posted: 5/22/2013 8:35:40 AM
From : Discussion Post>>Regulatory Open Forum
I think everyone has raised good points. I would only add some changes are underway for the EU system, which are important to know. If you have any questions don't hesitate to e-mail. ------------------------------------------- Marc Sanch...

RE:Device clearance in the EU
Posted: 5/22/2013 7:05:18 AM
From : Discussion Post>>Regulatory Open Forum
No. The most salient points in the US 510(k) clearance process is the concept of substantial equivalence. FDA defines the device risk class and provides additional requirements through the Product Code. A manufacturer demonstrates substantia...