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

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 to someone that was not heavily involved in the d...

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. While it may be useful to have a document of the thou...

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 that leaves little room for gray area and saves ti...

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 suspension or halted sale of the product. This can cos...

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 topical gel for scarring that was accompanied by a mas...

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 PMOA’s and the separation of two drugs until consumer...

Hello, Previously, I worked in the OTC pharmaceutical field but since becoming a full time graduate student, I have a stemmed interest in medical devices for women’s health and have recently become i...

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 usually wasn't in person, and that wasn't necessary an...