Secrets of Software Engineering in Medical Devices
Software is at the heart of many modern medical devices, but it also brings heightened regulatory complexity.
In this MedTechMan insight, Justin Bushko shares key principles that help teams navigate FDA expectations, manage risk, and build compliant medical device software with confidence.
Standards Drive the Software Lifecycle
Medical device software development is governed by strict standards, with IEC 62304 serving as a cornerstone. This standard defines how software should be planned, developed, tested, deployed, and maintained throughout its entire lifecycle. Following it from the beginning ensures consistency and creates a clear framework that both development teams and regulators can rely on.
Bugs Are Expected, Risk Is Not
A common misconception is that compliant software must be bug-free. In reality, nearly all software contains defects. The regulatory requirement is not perfection, but transparency. Teams must identify known bugs, explain why they exist, and demonstrate why they do not create unacceptable risk or patient harm. Clear risk analysis and justification are essential.
Planning Goes Beyond Coding
Successful medical device software development starts long before code is written. Teams must plan how testing will be performed, how software will be deployed, and how updates will be managed after the product reaches the market. Post-market maintenance is just as important as initial development and must be clearly documented.
Documentation Is Your Proof
Every decision, test, review, and approval must be documented in a clear and consistent way. Documentation should allow the FDA and your own internal teams to trace requirements through implementation and verification. Well-defined checkpoints and approvals provide evidence that the process was followed correctly and can be confidently defended during inspections.
Developing compliant medical device software is challenging, but with the right structure and experience, it’s manageable. If you’re working through IEC 62304 requirements or preparing for FDA review, Concise Engineering can help.
Justin Bushko
President, Concise Engineering
Next Steps
We hope you find this newsletter valuable and insightful.
If you have any questions, if you have feedback or would like to explore any specific topics further, please feel free to reach out to us.
Please email me at jbushko@concise-engineering.com or to book a call with me, click this link.
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