Compared to the Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) No. 2017/745 introduces a...
Understanding the classification of your medical device before CE marking is a critical step as it affects...
To maintain compliance with heightened requirements under the Medical Device Directive (i.e., recent Notified Body implementation of...
In our previous blog post, we described our preliminary regulatory research study on whether our client’s electronic...
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. The second, in a...
The last in a series of blogs about informal, pre-submission contact with FDA. Read the first here,...
The sixth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here,...
The fifth in a series of blogs about informal, pre-submission contact with FDA. See here, here, here,...
The fourth in a series of blogs about informal, pre-submission contact with FDA. See here, here, and...
The third in a series of blogs about informal, pre-submission contact with FDA. See here and here...
The second in a series of blogs about informal, pre-submission program and contact with FDA. See here...
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