Hardware Podcasts

Building Your Design Controls (and Pitfalls to Avoid)

Global Medical Device Podcast · 29 Mar 2023 · 35m · Episode 312

What this episode covers

Tom Rish, Director of Guru Services at Greenlight Guru, explains how to build effective design controls for medical devices by distinguishing between vague user needs and measurable design inputs. He argues that engineers should start from a clean slate rather than copy-pasting from previous Design History Files, as this prevents the solidification of tribal knowledge and leads to better designs. Rish emphasizes involving manufacturing, regulatory, and clinical teams early in the process to ensure the final product solves the actual clinical problem rather than just meeting arbitrary specifications.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Greenlight Guru
Tools
SolidWorks
Also
Tom Rish, Etienne Nichols, ISO 13485, FDA 21 CFR Part 820

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