-
Regulatory research on IDE exemptions: A case study in persistence (part 1)
A client presented us with a simple question – Do we need to submit an Investigational Device...
-
Regulatory Considerations for Clinical Studies: Clinical Trials for Medical Device Innovators Part II
Regulatory Considerations for Clinical Studies: Clinical Trials for Medical Device Innovators Part II. The second, in a...
-
Is the Pre-Submission process worth the time and effort?
The last in a series of blogs about informal, pre-submission contact with FDA. Read the first here,...
-
What happens once I submit a Pre-Submission? (Part 3: After the meeting)
The sixth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here,...
-
What happens once I submit a Pre-Submission? (The meeting)
The fifth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here,...
-
What happens once I submit a Pre-Submission? (Before the meeting)
The fourth in a series of blogs about informal, pre-submission contact with FDA. See here, here, and...
-
What is involved when submitting a Pre-Submission?
The third in a series of blogs about informal, pre-submission contact with FDA. See here and here...
-
When should you take advantage of the Pre-Submission program?
The second in a series of blogs about informal, pre-submission program and contact with FDA. See here...
-
What do I do if I want talk to FDA before I send in a submission?
The first in a series of blogs about informal, pre-submission program and contact with FDA. You are...
-
Seven ways to legally market your medical device in the U.S.
The vast majority of medical devices are marketed in the United States based on one of two...
OUR COMMITMENT
We are committed to consistently performing services with high quality, that deliver exceptional results, and add value to the client’s business.
For client surveys sent in the last two quarters, we received ratings of 4.98/5 points (9).