When True Process started medical software engineering work back in 2004, 100% of our projects were built using waterfall development processes. We didn’t have much of a choice — all of our customers used waterfall as well. Back then, you’d have a hard time convincing anyone in the medical device development field there was any other way.
In an article appearing on MDDI Online, Mayo Clinic software engineering manager Mark Wehde argues there is a better way. Much like the agile processes we currently use for software engineering, medical device developers can benefit greatly by adopting an iterative or evolutionary development methodology.
While using an evolutionary development methodology may seem to fly in the face of FDA-mandated design control processes, it doesn’t. The key is having well-defined and managed processes to assure your product is developed with necessary design and documentation controls.
We encourage you to read more at MDDI Online!
READ ARTICLE ON MDDIONLINE
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