Hardware Podcasts

Closing the gap between Regulatory and Development with Milton Yarberry

The Pragmatic Embedded Podcast · 5 Mar 2024 · 51m

What this episode covers

Milton Yarberry, Director of Medical Programs at Integrated Computer Solutions (ICS), discusses bridging the gap between engineering and regulatory teams in medical device development. He identifies key friction points such as process lag, software stacking, and the cognitive burden on developers, arguing that regulatory processes should be viewed as support rather than compliance burdens. Yarberry advocates for a 'regulatory concierge' model where regulatory staff handle administrative overhead, allowing engineers to focus on building safe and effective products through incremental, value-driven processes.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Integrated Computer Solutions, ICS, Bluefruit
Tools
Squish
Also
FDA, MDR, IEC 62304, Misra

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