Episodes

  • AI in medical devices under MDR and IVDR regulations

    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

    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

    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
  • EP-06 CSA Assurance Needs

    EP-06 CSA Assurance Needs
    Oct 13 2021
    CSA recommends Assurance Needs, right after Critical Thinking. What is Assurance Needs? This episode dives into this topic shedding light, based upon industry experience, on what to address in this phase of CSA validation.
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    26 mins
  • EP04 - How to be a Critical Thinker (Critical Thinking & CSA)

    EP04 - How to be a Critical Thinker (Critical Thinking & CSA)
    Sep 29 2021
    This podcast will give you skills to evaluate, identify, and distinguish between relevant and irrelevant information. This podcast will explain how you can be a critical thinker.

    For life science specifically, FDA's new Computer Software Assurance (CSA) validation methodology puts Critical Thinking at the forefront.

    In general, we live in a knowledge-based society, and the more critical you think the better your knowledge will be.

    Critical Thinking provides skills to analyze and evaluate information to attain the most knowledge about a subject, problem, solution, strategy, etc. Critical Thinking provides the best chance of making the correct decision while minimizing damages if a mistake is made.

    Utilizing critical thinking skills leads to becoming a more rational and disciplined thinker. It reduces prejudice, bias and provides a better overall understanding of a situation.
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    1 hr and 9 mins
  • EP03 - CSA (Computer Software Assurance). What's all the hype about?

    EP03 - CSA (Computer Software Assurance). What's all the hype about?
    Sep 22 2021
    CSA, short for Computer Software Assurance, is poised to make improvements on the 20-year-old Computer System Validation (CSV) practices life science organizations have been following. Is it new? Why all the hype? What is it, exactly? This episode explains how CSA is different from CSV, promising new opportunities that may be around the corner, and simply a better way to do something required by law (i.e., Validate systems).
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    18 mins