Common QMS Mistakes SaMD Companies Make


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What pitfalls do SaMD companies run into when they set up their QMS? How can your company avoid making these QMS mistakes?

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.

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.

Some of the highlights of this episode include:

  • 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.
  • Quality management systems come in several forms.
  • There are differences for QMSs at SaMD companies
  • Validating software means making sure it can do what needs to be done and produces consistent results
  • Issues or shortcomings that SaMD companies have with validating
  • For SaMD, intellectual data that you’re storing on your servers could be considered customer property and needs to be addressed in your QMS
  • It’s important to define specific roles and responsibilities for when the person ordinarily responsible for that role isn’t available.
  • The differences between AI and machine learning: AI basically mimics human behavior. Machine learning is more like a neural network.

Memorable quotes from Karandeep Singh Badwal:

“That’s one mistake that a lot of these software as a medical device companies are making. They just validate their own software.”

“Basically, what I’m looking for is evidence to prove you’ve done what you said, basically.”

“Customer property is one that I see a lot of Software as a Medical Device companies not addressing effectively.”

“Software as a Medical Device companies don’t realize that the software platforms they use are suppliers, and those need to be controlled.”

“The whole point of an internal audit is you want someone who’s independent.”


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