DEVELOPING SOFTWARE-DRIVEN DEVICES: TIPS TO HELP BRING TOMORROW’S MEDTECH TO MARKET TODAY

Sterling Medical Devices specializes in the design, development, and testing of software and electronics for medical product applications. In this article series, various experts from the firm will tackle issues related to the development of software-driven medical devices. Included among the topics covered are: safety assurance cases for FDA submissions, agile medical device software development, cybersecurity considerations for software-based devices, and software verification and validation (V&V).

For more information about Sterling Medical Devices, visit sterlingmedicaldevices.com.

ARTICLES IN THIS SERIES

Using Agile Project Management To Improve Medical Device Development
Friday, February 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.  Continue Reading..
How Safety Assurance Cases Can Improve Your FDA Submissions
Friday, October 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...  Continue Reading..
More Articles in this Series