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Clinical trial monitoring
Monitoring Clinical trial monitoring is a constantly evolving field, now encompassing various approaches that work together to...
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An important downside to eSTAR
If you are keeping abreast of FDA’s medical device efforts, then you know that as of October...
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On the Record: Compliance with 21 CFR Part 11 in Clinical Trials
What is 21 CFR Part 11? The United States Code of Federal Regulations (CFR) includes regulations for...
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Radiopacity evaluation of a medical device
During the summer of 2022, we expanded into a new space to better serve our customers. This...
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ISO 10993-17 Revision
The new version of ISO 10993-17 is expected to be published very soon. This is a major...
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Effective management of your clinical trial budget
Successfully executing a clinical trial is a large undertaking that requires strategic planning and cooperation. Even if...
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AIMD MRI safety
We recently updated our website to highlight our capability of evaluating the MRI safety of active implantable...
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Is your CRO providing the customer service and flexibility you need?
Over the last several years, there have been rapid changes in the industry. Most notably, there has...
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What is a contract research organization (CRO)?
A Contract Research Organization (CRO) is a company that provides clinical trial services for the pharmaceutical, biotechnology,...
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What is regenerative medicine?
Regenerative medicine is an interdisciplinary field that integrates engineering and life science principles to develop and deliver...
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Clinical evaluation reports (CERs) and working with scientific writers
Clinical evaluation is ongoing and necessary for medical device manufacturers. A manufacturer that sells its products in...
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Creating a Robust Clinical Evaluation Plan (CEP)
A clinical evaluation plan (CEP) may be necessary for your device. A medical device manufacturer that sells...
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 2024, we received ratings of 4.98/5 points (13).