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![Can the safe history of clinical use be used as justification for biocompatibility of a medical device?]()
Can the safe history of clinical use be used as justification for biocompatibility of a medical device?
Can the safe history of clinical use (no complaints registered in PMS) be used as justification not...
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![FDA grants MED Institute Accreditation Scheme for Conformity Assessment (ASCA)]()
FDA grants MED Institute Accreditation Scheme for Conformity Assessment (ASCA)
FOR IMMEDIATE RELEASE: August 18, 2021 Colleen Tennyson MED Institute 855.463.1633 ctennyson@medinstitute.com MED Institute Receives Accreditation through...
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![Clinical Trial Start-Up Top 5 Challenges]()
Clinical Trial Start-Up Top 5 Challenges
An efficient clinical trial start-up is essential to the success of a multicenter clinical trial. Initiating a...
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![Particulate Matter Spiking and Recovery]()
Particulate Matter Spiking and Recovery
In an earlier blog post, we identified the top three challenges for performing particulate testing: acceptance criteria...
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![Early Feasibility Studies: Top 6 Considerations]()
Early Feasibility Studies: Top 6 Considerations
Early feasibility studies (EFS) can be an important tool in the development of a novel medical device...
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![The Value of an ISO/IEC 17025:2017 Accreditation]()
The Value of an ISO/IEC 17025:2017 Accreditation
In 2004, we decided to institute an ISO/IEC 17025 quality management system designed specifically for calibration and...
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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...
