Writing a software development and maintenance plan is the first step of documenting our software. But before we get our feet wet with regulatory documentation, let's briefly understand the requirements of regulatory work at your startup and the IEC 62304 without falling asleep.
Regulatory work consists of two parts:
Firstly, the "company" part which mostly consists of setting up an ISO 13485 - compliant quality management system. We won't be talking about this here and hopefully you have someone in your company dealing with this.
The second part is the "product" part in which you document your product (= your software). This is what we're talking about in this course.
We'll briefly look at how we'll map the IEC 62034 section numbers to our documents. I'll also briefly explain that some IEC 62304 software safety classes require you to do more documentation than others.
We'll skim over some headlines in the standard to get a better understanding of what it requires you to do.
Next, we'll need to understand the V-Model. What the hell?
The V-Model is a concept which the IEC 62304 (more or less) refers to - the idea is that you have different steps, at least in your documentation, and each step produces certain documents. We'll briefly see how the V-Model steps map to our process document (SOP Software Development).