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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...

    Read More
  • EU MDR Extension

    EU MDR Extension

    Although the implementation of EU MDR has been postponed for up to one year, it will be...

    Read More
  • 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...

    Read More
  • 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...

    Read More
  • 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...

    Read More
  • 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...

    Read More
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MED Institute | Accelerate your product development.

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