Author: Dylan Horvath

Tips & Resources

Design for Manufacturing (DFM): Principles, Processes, and Best Practices
ByDylan Horvath 2025-09-052025-09-07

What Is Design For Manufacturing (DFM)? Design for Manufacturing (DFM) is the practice of refining product designs so they can be produced reliably and cost-effectively at scale using standard manufacturing methods. For instance, a prototype that works on a 3D printer may not be feasible for mass production with injection moulding. DFM bridges that gap,…

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Tips & Resources

FDA 510(k) Process Explained: What to Know About Premarket Notification
ByDylan Horvath 2025-08-122025-08-13

For companies looking to bring moderate-risk medical devices to market, navigating the FDA’s 510(k) premarket notification process is essential and often complex. This guide breaks down the fundamentals of a 510(k): what it is, how the process works, and the practices that can make or break your submission, but most importantly, it emphasizes the need…

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