AI in medical devices under MDR and IVDR regulations
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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5:48
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5:48
EP-08 CSA Documentation
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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16:13
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16:13
EP-07 CSA Testing
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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47:50
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47:50
EP-06 CSA Assurance Needs
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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25:31
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25:31
EP04 - How to be a Critical Thinker (Critical Thinking & CSA)
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.
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.
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