Developing Medical Device Software – Blog

“Developing Medical Device Software,” new Med Device Online article series by Sterling Medical Devices

While nowadays Safety Assurance Cases are mostly limited to infusion pumps, medical device software companies should consider preparing for a potential expansion of this case practice according to Sterling Medical Devices engineering managers, Steve Hartman and Nick Oshman, authors of a Med Device Online series, “Developing Medical Device Software: Tips to Help Bring Tomorrow’s Medtech to Market Today”. In their article, Steve and Nick explain what a safety assurance case is, the history of safety assurance cases for infusion pumps, and how they are used in the medical device industry today. Additionally, they provide insights on how adoption of safety assurance cases as a best practice can:

  • Enable regulators to “connect the dots” so that they can see medical devices claims and the evidence that supports those claims
  • Allow medical device developers to align their product development efforts with FDA expectations
  • Help to speed up regulatory approval processes

See what else they have to say about safety assurance cases by reading the full article. You can also check out a recent video, where Nick (one of the authors) explains ISO 14971 in under a minute.

Stay tuned for more expert insights on developing medical device software.