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Agile Compliance - Software development planning

Written by
Wolfgang Huber

In order to ensure an organized and efficient software development process, it is imperative to maintain an up-to-date and well-documented software development plan, as stated in sections 5.1.1 and 5.1.2.

It cannot be a collection of (uncontrolled) confluence pages or word documents. It needs to be a controlled document, meaning it needs to be written, reviewed, approved and released and version controlled. It needs to be clear when each version of the plan was used, and which documentation was written according to which version of the plan.

What has to be covered by the software development plan?

The plan needs to take the software safety classification into account, and therefore will be more extensive for Class C compared to class A software.

Written by
Wolfgang Huber
Founder

Wolfgang Huber has spent his career at the intersection of software engineering and the medical device industry - a combination that turned out to be exactly what the market needed. After earning a Master's degree in Computer Science in Germany, he spent 20 years building and scaling technology startups, including a stint as VP R&D at Advanced Medical Diagnostics and co-founder of NeoMed Software. That experience gave him a deep understanding of both the technical complexity and the regulatory burden facing medtech teams. In 2014, together with Yves Berquin, he spotted a gap no existing tool was filling: medical device companies needed a smarter, more flexible way to manage software requirements and quality documentation as the industry moved from waterfall to agile. So they built it themselves bootstrapping Matrix Requirements (which is now Matrix One) from zero to a globally recognized leader.

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