Hardware Podcasts

Are you Spending Enough Time Defining and Managing Requirements for your Medical Device?

Global Medical Device Podcast · 18 Nov 2020 · 35m · Episode 168

What this episode covers

Devin Mack, mechanical engineer and owner of Enqual, discusses the critical importance of defining and managing requirements in medical device product development. He argues that companies should spend approximately one-third of their project time on this phase to avoid chaos and ensure market fit. Mack advocates for early cross-functional involvement from quality, manufacturing, and regulatory teams, rather than siloed engineering efforts. He also shares his 'stoplight' methodology for tracking progress against customer specifications and emphasizes the need for usability models to get it right the first time.

Most relevant to

established companies

Topics

Mentioned

Companies
Enqual, Greenlight Guru
Also
FDA, ISO 13485, EU MDR

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