We work with outside companies that design/develop our commercial medical devices. So I indirectly come into contact with DHFs, but don't have an infl...
Tech File is required regardless of the class of device in the EU, whereas in the US the FDA requires a 510(k)for Class II and higher. Another differe...
Another difference between 510k submission and a technical file is that the 510K is for Class II and above in the US. Whereas the technical file is r...
I agree with the posts mentioned above. Device companies have been seeking early approval in Europe for years because it is easier. I think the two ma...
Like @srg36, I found the 2005/50/EC directive about the reclassification of hip, shoulder and knee devices from Class IIb to Class III. I also found ...
I think the First Digital Pill in US, Abilify MyCite opens up concerns about patient privacy, but also paves the way for other digital pills. For exam...
I agree with @wms7 that the Office of Combination Products (OCP) would review the primary mode of action (PMOA) to determine the agency assigned; CD...
I think if the company wants to be successful, they need to take the regulatory submission process seriously and not embellish how similar a device is...
Participation, the fifth P of marketing, is crucial when marketing a product. You need to engage your potential client(s). At Sloan we actively market...
I work in the office of technology development at Sloan Kettering and oversee the medical device portfolio. The trends I see that Investors/companies ...
Yes, I used to work in the contracts unit at Sloan Kettering. I worked on Material Transfer Agreements (MTAs), Confidentiality Agreements (CDAs), Data...
I agree with the posts thus far that interpersonal skills are crucial to succeeding. As Ken Blanchard states" None of us is as smart as all of us". Wh...
I work for Sloan Kettering, and the organization is matrixed. I work in the office of technology development in the licensing group, which would seem ...
I agree with @srg36 and @cdj24 that the four categories are in order. Upper management is responsible for developing the strategic plan and how it can...
Dr. Simon, I really enjoyed this course. I found the Regulatory and Quality lectures to be very informative and useful. I work more on the business s...