Strategic Insight Shaped by Decades of FDA Leadership
RHOMEDx LLC helps organizations make sound regulatory decisions before issues become costly problems. Founded by Rhonda Mecl, a former FDA Deputy Director with 36 years of experience in FDA inspections, medical device oversight, and regulatory compliance, RHOMEDx provides strategic guidance grounded in real-world regulatory experience.
Throughout her FDA career, Rhonda trained investigators, mentored supervisors and managers, and championed a practical, risk-based approach to regulatory oversight. She also developed a reputation for bringing clarity to one of the agency's most common answers: "it depends." Today, she helps organizations understand not only what regulations require, but also the rationale behind regulatory decisions and how compliance expectations are applied.
Working with medical device, life sciences, and public health organizations, RHOMEDx helps leaders understand regulatory expectations, strengthen quality systems, prepare for inspections, manage recalls and compliance challenges, and drive continuous improvement. The result is more informed decision-making, stronger organizational resilience, and greater confidence when facing regulatory scrutiny.
strengthen quality culture 〰️ improve risk decisions 〰️ optimize strategic communications
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strengthen quality culture 〰️ improve risk decisions 〰️ optimize strategic communications 〰️
Advisory Services
Executive Regulatory Advisory
Strategic counsel that helps leaders interpret regulatory change, assess risk, and establish clear, defensible priorities.
Recall & Post-Market Risk
Integrated analysis of recalls, complaints, adverse events, inspections, and surveillance data to identify emerging issues and guide risk-based actions.
Inspection Readiness & Compliance
Practical guidance to strengthen quality systems, CAPA, governance, and continuous improvement through collaborative, role-based training.
Regulatory Communications & Stakeholder Engagement
Collaborative preparation for agency inquiries and high-stakes matters, including message development, stakeholder alignment, response-team coaching, and communication training.
Quality Systems & Continuous Improvement
Readiness assessments, interview preparation, and training that equip teams to respond confidently, and improve your own audit team to sustain compliance.
Leadership & Organizational Effectiveness
Advisory support, leadership education, and customized training that clarify roles, strengthen company culture and accountability, and build high-performing regulatory and quality organizations.
Let’s talk about your needs.
Short or long-term projects. Describe your vision and project ideas to receive a tailored engagement outline. Let’s see what works best for both of us. We’ll talk soon.
Thank you-
Rhonda
218-322-1976
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. At this level, I led the development of national policy, which required a practical mindset rather than a rigid reliance on regulations. I managed daily strategy, compliance, and high-stakes inspections worldwide. Before I left, I used my pre-QSIT experience and inspection data analytics to help formulate an inspection approach for the new QMSR regulations.
My expertise was developed during more than two decades in the FDA’s Minneapolis office, leading field operations, developing investigator expertise, and mentoring managers. This experience made me a trusted liaison to agency headquarters, translating complex federal requirements into practical strategies and leading enforcement that protected public health while supporting 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 needed to use my lifetime of insider experience to help companies cut through the jargon, navigate regulatory hurdles, and build quality systems that work in the real world and withstand inspection scrutiny.