Product Development Lifecycle

RECENT BLOGS

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  5 Aspects of Device Clinical Study Close-Out

  A clinical study process that is often underappreciated is close-out. Regardless if the study was completed or...

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  Completing clinical study enrollment and what’s next

  Great job on completing enrollment! Reaching this major milestone is a big accomplishment as it marks the...

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  Key Takeaways from the FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment – Part 2 of 2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  Key Takeaways from the FDA Draft Guidance on Chemical Analysis for Biocompatibility Assessment – Part 1 of 2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...

  Read More
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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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