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MED Institute welcomes Ted Heise, PhD
For Immediate Release: Bloomington, Ind. – Med Institute Inc. today announced Ted Heise as the new vice...
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5 Tips for Medical Device Sponsors for Running a Successful Clinical Trial
Everyone is demanding more clinical evidence from medical device companies these days. FDA wants to see more...
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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,...
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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,...
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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,...
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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...
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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...
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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...
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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...
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The medical device product lifecycle is challenging. We can help you through all of the steps!
MED recently exhibited at MD&M West in Anaheim, CA. We were so excited to begin the trade show...
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Uncertainty Analysis is an Important Part of Test Method Validation
“Testing” is a term that covers a vast range of activities. Not every test is a measurement;...
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The Goals of Test Method Validation
Test method validation is a documented process that is used to confirm that the procedure to be...
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