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Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives
The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...
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How does an Early Feasibility Study differ from a Pivotal Study?
An Early Feasibility Study (EFS) is performed early in the device development process to evaluate the device...
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Hybrid Clinical Trials in the Age of COVID-19 and Beyond
We were recently invited by the orthopedic market intelligence firm ORTHOWORLD® to describe our experiences with clinical...
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Remediation, Regulatory Compliance, and Company Culture
FDA Warning Letters are devastating – a Quality Manager’s worst nightmare – a major shock to any...
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EU MDR Extension
Although the implementation of EU MDR has been postponed for up to one year, it will be...
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Top 3 Challenges for Particulate Matter Evaluation
There are several safety concerns (risks) for patients who require a minimally invasive procedure. One of the...
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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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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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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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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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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...
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).