Developing Software Articles in this Series

1. Using Agile Project Management To Improve Medical Device Development 2/12/2016

   Writing medical requirements during the early stages of device development is important, but assuming they will not change is folly. Because development is a process of incremental discovery, agile project management practices are increasingly popular for addressing challenges that occur during the product development lifecycle.

2. How Safety Assurance Cases Can Improve Your FDA Submissions 10/2/2015

   A recent FDA report points to software design failures as the most common cause for medical device recalls. However, an approach that has been used since 2010 to evaluate the safety of infusion pumps is garnering interest from medical device companies to help address these challenges: Safety Assurance Cases. A safety assurance case offers a promising answer to the question of how to streamline processes for FDA reviewers, because it allows them to clearly understand what a medical device developer is claiming for its software, and then helps guide the reviewers through evidence that supports the developer’s safety and efficacy claims.