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![Patient Engagement in Clinical Trials: Patient, Industry, and Clinical Investigator Perspectives]()
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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![External Fixation Devices]()
External Fixation Devices
An external fixation device refers to a device that provides stability and alignment for fractured bones and...
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![How does an Early Feasibility Study differ from a Pivotal Study?]()
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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![Quality System Remediation and Root Cause Analysis]()
Quality System Remediation and Root Cause Analysis
Successful quality system remediation relies on understanding why problems arose, generally referred to as “root cause analysis.” ...
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![Hybrid Clinical Trials in the Age of COVID-19 and Beyond]()
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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![Using Patient Preference Information (PPI) for Patient-Centered Medical Device Development]()
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]()
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]()
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]()
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]()
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...
