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RAPS 2020 Convergence
RAPS 2020 Convergence is going virtual this September! We’re sorry that we won’t be able to meet...
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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FDA Draft Guidance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...
