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Life Sciences Live

Life Sciences Live

Written by: Steven Thompson
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About this listen

Life Sciences Live brings you the latest insights, trends, and discussions at the intersection of life sciences, technology, and innovation.

Hosted by industry experts, this podcast explores cutting-edge topics such as AI in healthcare, regulatory compliance, and groundbreaking advancements shaping the future of pharmaceuticals, biotechnology, and medical devices. Join us for thought-provoking interviews and practical takeaways to stay ahead in the ever-evolving world of life sciences.

Brought to you by INTEKNIQUE.AI, where technology meets compliance and innovation thrives. Visit inteknique.ai.com to learn more.copyright - 2024 INTEKNIQUE, LLC. - all rights reserved
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Episodes
  • AI in medical devices under MDR and IVDR regulations
    Nov 26 2024
    Explore the transformative role of Artificial Intelligence in the medical device industry under the European MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). This episode delves into the regulatory landscape, compliance challenges, and opportunities for innovation, offering valuable insights for professionals navigating these critical frameworks in life sciences.
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    6 mins
  • EP-08 CSA Documentation
    Oct 28 2021
    Is "Documentation" really the focus of CSA even if it's placed at the lowest level of the pyramid? In this episode, I'll cover the last in a series dedicated to Computer Software Assurance (CSA), from Critical Thinking, Assurance Needs, Testing, and now Documentation.
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    16 mins
  • EP-07 CSA Testing
    Oct 20 2021
    CSA Testing is the third level tier in the upended pyramid that is poised to disrupt Computer System Validation (CSV) or at least provide a refresher for Risk-Based Validation with a Least Burdensome approach, along with different testing modalities such as ad hoc, exploratory, and automated testing. This podcast dives into Testing in CSA, along with highlighting a root cause common with poor test scripts and test steps.
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    48 mins
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