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![Exploring the EU MDR’s Impact on ‘Legacy’ Medical Devices]()
Exploring the EU MDR’s Impact on ‘Legacy’ Medical Devices
Devices already legally on the market under the European Union’s (EU) Medical Devices Directive (MDD) or the...
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![Radiopacity Evaluation and The Top 10 Challenges]()
Radiopacity Evaluation and The Top 10 Challenges
The ability to visualize a minimally invasive medical device or product during use is an important consideration...
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![Electronic Clinical Outcome Assessment (eCOA)]()
Electronic Clinical Outcome Assessment (eCOA)
Electronic Clinical Outcome Assessment (eCOA) is a method of capturing outcomes data electronically in clinical trials. eCOA...
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![Virtual Clinical Trials]()
Virtual Clinical Trials
New and refined technologies have allowed for novel data collection strategies in clinical trials. “Virtual” visits allow...
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![RAPS 2020 Convergence]()
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]()
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]()
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]()
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]()
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]()
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]()
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]()
Test Method Development and Validation
The requirements associated with medical device safety testing continue to increase, which has raised the bar for...
