What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes?
Today\u2019s 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.
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.
\u201cThat\u2019s one mistake that a lot of these software as a medical device companies are making. They just validate their own software.\u201d
\u201cBasically, what I\u2019m looking for is evidence to prove you\u2019ve done what you said, basically.\u201d
\u201cCustomer property is one that I see a lot of Software as a Medical Device companies not addressing effectively.\u201d
\u201cSoftware as a Medical Device companies don\u2019t realize that the software platforms they use are suppliers, and those need to be controlled.\u201d
\u201cThe whole point of an internal audit is you want someone who\u2019s independent.\u201d
Karandeep Singh Badwal's LinkedIn
etienne.nichols@greenlight.guru