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Using Patient Preference Information (PPI) for Patient-Centered Medical Device Development
There is much interest in engaging patients in the medical device development process, at all stages of...
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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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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) is a method of capturing outcomes data electronically in clinical trials. eCOA...
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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 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...