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Early Feasibility Studies
The EFS (Early Feasibility Study) process is a regulatory pathway created by FDA to facilitate the study...
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Top 10 Challenges for MRI Safety Evaluation
There are several safety concerns for patients with metallic implants who require MRI, including magnetic forces, torques,...
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5 Reasons your Clinical Trial has Poor Patient Enrollment and Retention
Adequate patient enrollment and retention are absolutely essential to the success of a clinical trial. A study...
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FDA Remediation Services
Have you been issued an FDA Form 483 or Warning Letter? We can relate to how stressful...
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Early Feasibility Studies (EFS) Program
The idea of the Early Feasibility Studies (EFS) program was first published in 2011 as a FDA...
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Pushing the limits of medical device design
Our multi-disciplinary team has extensive experience in medical device research and development, including but not limited to...
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Test Method Development and Validation
The requirements associated with medical device safety testing continue to increase, which has raised the bar for...
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MRI Safety of Electrically Active Devices
We have recently expanded our capabilities to include MRI safety evaluation of electrically active devices to our...
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COVID-19 Update
Dear valued clients, With the rising global concern around COVID-19, we wish to let you know that...
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European Medical Device Regulation (MDR)
The European Medical Device Regulation (MDR) is a new set of regulations that will become effective May...
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FDA Draft Guidance
Our multi-disciplinary team has extensive experience in medical device simulation and testing, including but not limited to...
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Claiming Equivalency Under EU Medical Device Regulation
Compared to the Medical Device Directive (MDD) 93/42/EEC, the Medical Device Regulation (MDR) No. 2017/745 introduces a...
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).