Verification is making sure that the product/ device is functional and performs as it should. It entails testing, inspections, and analysis. Validatio...

In my opinion, the tech file/dossier is more useful. The reason being is that it gives an overview to the entire product and design and is most useful...

I think that the DHF should be a live document. The reason being that from experience, the original idea of the device is rarely ever the outcome. Whi...

I would tend to say that device approval is easier in the EU because it is faster. And it is faster because it is simpler and is based on a checklist ...

I would say that NB-MED guidance documents are the most useful to follow. The notified bodies have the power to inspect devices and can lead to a susp...

Great question, Fady! I have some experience with filing combination drug product in the EU. One instance, in particular, that comes to mind is a topi...

Hello Fady, I have a small amount of experience in working with PMOA’s for combination products. In my experience, I have worked with drug/device PM...

Hello, Previously, I worked in the OTC pharmaceutical field but since becoming a full time graduate student, I have a stemmed interest in medical de...

Hello Andrew When I worked in industry and had trouble getting contracts signed and have input on everything, I would often request a meeting. It usu...