Rhonda Mecl

The Story of My FDA Career

I spent 36 years at the FDA, and while I rose to top leadership roles, I always believed the best way to get things done was by being a real person within a massive bureaucracy.

In my final few years, I served as Deputy Program Director and Operations Staff Director for the Office of Medical Device and Radiological Health Operations within the agency’s inspection operations. I managed daily strategy, compliance, and high-stakes inspections worldwide. At this level, I lead the development of national policy, which required a practical mindset, rather than a rigid reliance on regulations.

The executive-level work was built on over two decades in the FDA's Minneapolis office, leading field operations. Knowing the reality of the ground-level work made me the go-to bridge to agency headquarters. My job was to translate complex federal rules into clear, real-world strategies and to execute regulatory enforcement that protected public health without stifling medical innovation.

It all started as a field investigator in Portland, Oregon, where I always volunteered for complex and unusual cases. Once I realized that I belonged in medical devices, I returned home to Minnesota to immerse myself in the industry's “Medical Alley”. That hands-on experience gave me a deep understanding of the practical challenges companies face.

After more than three and a half decades of public service, I stepped away in 2025.

I started RHOMEDx LLC on the heels of the 50th anniversary of the US’s Medical Device Amendments, realizing that I need to use my lifetime of insider experience to help companies cut through the jargon, navigate regulatory hurdles, and help build quality systems that work in the real world and withstand inspection scrutiny.

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