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Key Takeaways from the FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment – Part 2 of 2
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
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Key Takeaways from the FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment – Part 1 of 2
Within the last five years, there has been significant advancement in chemical analysis and toxicological risk assessment...
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Understanding the Key Players in a Clinical Research Trial
In a clinical research trial, or study, various roles are crucial to ensuring the study’s success and...
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Leveraging Surface Characterization: Emerging Trends in Biocompatibility Tests
Finding the least burdensome pathway to address biocompatibility requirements can be a challenge. Coupling our engineering and...
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Artificial Intelligence in Clinical Studies
Artificial Intelligence (AI) is a growing field of interest for many industries, including those of medical devices...
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Selecting the Right Electronic Data Capture (EDC)
What is EDC? EDC stands for electronic data capture. This usually refers to the processes of an...
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Phases and Stages of Clinical Trials
Clinical research for pharmaceuticals and devices follows the same general path. The first trial is a small...
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Decentralized Clinical Trials
Decentralized clinical trials (DCTs) are becoming increasingly popular, with the increased use of electronic systems and novel...
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The Value of a Clinical Events Committee (CEC)
What is a CEC? In clinical trials that include a high-risk patient demographic, a clinical events committee...
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The Power of Post-Market Clinical Data
For medical devices, ensuring safety and efficacy doesn’t stop once a product hits the market. Post-market clinical...
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EU MDR Article 61 Clinical Evaluation
The European Union (EU) Medical Device Regulation 2017/745 (EU MDR) aims to ensure a high level of...
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Challenges of Demonstrating Biological Equivalence per ISO 10993-18 and EU MDR
In the European Union (EU), a device is considered equivalent if it fulfills all the requirements of...
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