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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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MRI Safety Labeling of Medical Devices: Change Is on the Horizon
If you missed us at RAPS Convergence 2021, you can reach out to our team and we...
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CRO selection: How to get it right the first time
CRO selection can sometimes be difficult to navigate. “My favorite meeting to have with a CRO is...
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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 (no complaints registered in PMS) be used as justification not...
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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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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
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 (EFS) can be an important tool in the development of a novel medical device...
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What is a Clinical Evaluation Report (CER)?
A Clinical Evaluation Report (CER) is a detailed summary of the evaluation of information pertaining to clinical...
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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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