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Episode 285  |  42:39 min  |  10.20.2022

Common QMS Mistakes SaMD Companies Make

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This is a podcast episode titled, Common QMS Mistakes SaMD Companies Make. The summary for this episode is: <p>What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes?&nbsp;</p><p>Today’s guest, Karandeep Singh Badwal, is a Regulatory Affairs Quality Consultant who is well-versed in EU MDR, and regularly works with medical companies producing Class I, II, and III medical devices.</p><p>Listen as we talk about what a quality management system is and what the goal of a QMS is, the importance of validating software, and the differences between AI and machine learning, among other things.&nbsp;</p><h3>Some of the highlights of this episode include:</h3><ul><li>A quality management system is a structured system of procedures and processes covering all aspects of design, manufacturing, supply, risk management, management responsibilities, customer-related processes, corrective actions, and preventative actions.</li><li>Quality management systems come in several forms.</li><li>There are differences for QMSs at SaMD companies</li><li>Validating software means making sure it can do what needs to be done and produces consistent results</li><li>Issues or shortcomings that SaMD companies have with validating</li><li>For SaMD, intellectual data that you’re storing on your servers could be considered customer property and needs to be addressed in your QMS</li><li>It’s important to define specific roles and responsibilities for when the person ordinarily responsible for that role isn’t available.</li><li>The differences between AI and machine learning: AI basically mimics human behavior. Machine learning is more like a neural network.</li></ul><h3>Memorable quotes from Karandeep Singh Badwal:</h3><p><em>“That’s one mistake that a lot of these software as a medical device companies are making. They just validate their own software.”</em></p><p><em>“Basically, what I’m looking for is evidence to prove you’ve done what you said, basically.”</em></p><p><em>“Customer property is one that I see a lot of Software as a Medical Device companies not addressing effectively.”</em></p><p><em>“Software as a Medical Device companies don’t realize that the software platforms they use are suppliers, and those need to be controlled.”</em></p><p><em>“The whole point of an internal audit is you want someone who’s independent.”</em></p><h3>Links:</h3><p><a href="https://www.linkedin.com/in/karandeepbadwal/" rel="noopener noreferrer" target="_blank">Karandeep Singh Badwal's LinkedIn</a></p><p><a href="https://www.youtube.com/channel/UC1ygqJO7_HV30XVdHyN-0lg" rel="noopener noreferrer" target="_blank">Karandeep’s YouTube</a></p><p><a href="https://open.spotify.com/show/32CvtseLj3KknqYDFdO7P3" rel="noopener noreferrer" target="_blank">MedTech Podcast</a></p><p><a href="https://www.linkedin.com/in/etiennenichols/" rel="noopener noreferrer" target="_blank">Etienne Nichols LinkedIn</a></p><p><a href="http://etienne.nichols@greenlight.guru" rel="noopener noreferrer" target="_blank">etienne.nichols@greenlight.guru</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a></p><p><a href="https://community.greenlight.guru/" rel="noopener noreferrer" target="_blank">MedTech Excellence Community</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a></p><p><br></p>