Medical device software development and compliance: How can Bluefruit help?

TIR 45 provides guidelines for the development of medical devices using Agile practices. Since publication in 2012, the medical device community has accepted that not only is Agile compatible with medical device standards (such as IEC 62304), but it can actually deliver a more successful and higher quality solution. The guide explains to a sceptical Quality Manager how compliance can be achieved with Agile; also, the guide explains to an experienced Agilista how Agile principles can be preserved in a regulatory environment. However, understanding the theory is only the first step; putting TIR 45 into practice can be challenging.

At Bluefruit, we do not provide standard training services. We provide expert software development teams that can work alongside your teams, providing training by “osmosis”. Alternatively, we can provide a complete software solution for your project.

How can Bluefruit help with TIR 45 adherence?

Here are a few examples:

Executable Requirements

A classic problem for QA teams is how to keep strong alignment between requirements documents and test plans; i.e. making sure we’re testing the right thing. One Agile solution to this problem is executable requirements – a format of requirement specification that enables the automatic generation of associated test cases. Bluefruit can setup a full test framework for your project using a toolkit we’ve developed over the past ten years. And as TIR45 highlights, there are also obvious quality benefits from immediate feedback to the team and reassurance to managers that requirements are being met.

Agile Quality Management System (QMS)

A common cause for traditional waterfall projects to fail is a failure to respond to emergent knowledge. This is particularly common in medical device projects where there is a quality management system that creates impediments to change. Bluefruit’s Agile pedigree has meant that our QMS has been built around our Agile philosophy. We can adapt our QMS to fit your business, or we can help you to adapt yours to better-enable an Agile approach.

Evolutionary Lifecycle

In manufacturing, quality means reducing variation from “the plan”. However, in engineering the goal is to deliver a design that is fit for purpose. For this goal, you need a discovery process that embraces and adapts to emergent knowledge. An evolutionary lifecycle accepts that the user’s needs are not entirely understood at the start of a project. So when should you formalise your requirements? When should you verify and validate your software? TIR 45 answers these questions and Bluefruit can demonstrate this lifecycle working, in practice and on your project.

What to know more? We’re always happy to talk.

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