Product Development, Human factors engineering
Product Development, Human factors engineering

Reverse Engineering in Medical Device Design: When and Why It Makes Sense

By Khushali Solanki

Reverse engineering carries a reputation problem in medical device circles; it sounds like copying. In practice, it’s a legitimate engineering discipline with specific, defensible use cases: replacing obsolete components, improving an existing design’s manufacturability, and indigenizing imported parts. This article looks at when reverse engineering genuinely makes sense in medical device development, the technical process involved, and the intellectual property considerations teams need to navigate before using it.

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Taking the Headache out of Maintaining 21 CFR Compliance

By Bryan Christiansen

Overcoming 21 CFR compliance challenges – stringent equipment maintenance requirements, overwhelming documentation demands, the need to maintain data integrity. Insights into challenges healthcare organizations face with compliance and how to incorporate new tools and processes for streamlining maintenance processes, reducing compliance burdens, and ensuring the highest standards of safety and efficiency.

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