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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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Why do I need test method validation and what level of rigor is necessary?
The medical device industry has long understood the requirements related to process and software validation, however, US...
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MedTech Policy Forum
On September 20th Justin Renfrow, Director of Business Operations, participated in the 2016 MedTech Policy Forum. This...
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What Should You Do When a Testing Standard Doesn’t Exist? Part 6: Overcoming Standard Committee Stalemate
In part five of this series, we discussed forming an industry consortium as another means to develop...
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MD&M Minneapolis 2016
We ended our 2016 tradeshow season in Minneapolis, MN at MD&M Minneapolis – September 21 and 22nd....
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What Should You Do When a Testing Standard Doesn’t Exist? Part 5: Forming an Industry Consortium
In part four of this series, we talked about employing a third party to build testing equipment...
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Meet Bill Voorhees,our Vice President and Chief Science Officer.
I’m Bill Voorhees. I have been employed by MED Institute for over 25 years, although I have...
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