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Hello everyone, Recently, I have been dealing with some troubles with documentation required for registration in non-EU countries, especially on Asian markets. We are a manufacturer of active devices with measuring function class IIa and we deliver o...

I found the "The Eye Doctor Essential®" on Amazon. What would be the device classification according to the new MDR? I believe it would be a Class IIa because it produces heat. Is this right? Thanks you!

My client has a new therapy they are launching in Q1 and I need a partner to help me develop and market a CME educational program to the clinical community. Please respond here with any resources - thank you and Happy New Year!

Hi! We've been having a long discussion with a Notified Body and we aren't satisfied with the answer.There is a ME1 device which is connected to mains plug (230 V - 50 Hz input) and is totally reinforced and insulated. The sample (ME2) is connected t...

This is my new stock answer whenever a medical device hopeful needs capital. Fill out this form. If you can't answer the questions on this form, your prospective investors ("smart money," if you will) don't have enough information. Take your pick: as...

Hi all. If my EC representative is presently based in the UK, do I have to change him? If so, by what date?What is the BREXIT on non-EU manufacturers with UK-based representation?

Hi All. I was wondering if anyone has seen a big move away from producing documentation (exc NB submissions etc) in these modern times! Before anyone has a heart attack, I will try and explain.With the vast array of software tools at our disposable, ...

As a General Surgeon, I'm passionate about medical device development, particularly as it relates to health economics and healthcare delivery in general. I would like to gain a better understanding of the reimbursement structure in the US (I'm at Ber...