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Real-World Data Are Everywhere. Useful Real-World Evidence Takes Planning
For many sponsors, real-world data can be both an opportunity and a risk. The right data source...
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Whitepaper Series: How MED Institute Accelerates Product Development – Insights into Each Core Capability
At MED Institute, we understand that selecting the right partner for medical device development is a critical...
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ISO 14155:2026 Changes
Introduction to ISO 14155 The International Organization for Standardization (ISO) develops independent, international standards in various sectors...
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EU MDR Clinical Evaluation Technical Documentation
Overview For CE marking and throughout the device’s lifecycle, medical device manufacturers must demonstrate conformity with Regulation...
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Overcoming the Challenges of Biological Product Development in a Complex Regulatory and Economic Landscape
What are Biological Products? A biological product or “biologic” is a broad term for living material-derived larger...
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ISO 10993-1 Revision Highlights Part 4: Reinforcement of Material and Chemical Characterization
Read previous posts in this series Part 1, Part 2, and part 3. The importance of material...
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ISO 10993-1:2025 Revision Highlights Part 2: Exposure Duration = Exposure + Duration
Calculation of Exposure Duration for Categorization of Medical Devices While exposure duration is not a new concept...
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Medical Imaging in Clinical Trials
Medical imaging is a routine practice for healthcare professionals. The images produced are used as a clinical...
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How to Start a Clinical Trial: 10 Steps to Meet FDA Standards
Starting a clinical trial is a critical milestone in bringing new medical products to market. Whether you...
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Rethinking Representation in Clinical Research – Who’s in the Study?
Introduction The underlying principle of a clinical study is to assess the safety and efficacy of an...
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Patient-Reported Outcome (PRO)
“What matters is this – will it help patients?” ~ Bill Cook Introduction To ensure that patients...
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The Impact of GCP R3 on Your Trial Master File
Introduction The third revision (R3) of the International Council for Harmonisation (ICH) Good Clinical Practice (GCP) was...
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