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Change Management

Let's see how we manage changes after the first version of our software is certified as a medical device.

How painful is changing your software after it's been released and certified?

We'll have a look at what the IEC 62304 requires when it comes to changes what sort of documentation you need to create. We'll talk about Change Requests and how to document them in the tool of your choosing.

Next, we'll look into the concept of a "substantial" change which requires you to inform your notified body prior to shipping the change. What is a substantial change, anyway? I'll walk you through the most important sections in the guidance document MDCG 2020-03 (see link below).