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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...

    Read More
  • 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
  • Virtual Clinical Trials

    Virtual Clinical Trials

    New and refined technologies have allowed for novel data collection strategies in clinical trials. “Virtual” visits allow...

    Read More
  • 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...

    Read More
  • Early Feasibility Studies

    Early Feasibility Studies

    The EFS (Early Feasibility Study) process is a regulatory pathway created by FDA to facilitate the study...

    Read More
  • 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,...

    Read More
  • 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...

    Read More
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MED Institute | Accelerate your product development.

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