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What is a contract research organization (CRO)?
A Contract Research Organization (CRO) is a company that provides clinical trial services for the pharmaceutical, biotechnology,...
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What is regenerative medicine?
Regenerative medicine is an interdisciplinary field that integrates engineering and life science principles to develop and deliver...
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Clinical evaluation reports (CERs) and working with scientific writers
Clinical evaluation is ongoing and necessary for medical device manufacturers. A manufacturer that sells its products in...
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Creating a Robust Clinical Evaluation Plan (CEP)
A clinical evaluation plan (CEP) may be necessary for your device. A medical device manufacturer that sells...
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FDA grants MED Institute MDDT (Medical Device Development Tool) qualification
West Lafayette, IN: MED Institute obtained FDA qualification of their MDDT (Medical Device Development Tool) for virtual...
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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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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
The Medical Device Innovation Consortium (MDIC) Science for Patient Input initiative has been working to promote patient-centered...
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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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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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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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