Medical Device Consulting
Engineering the Path from Concept to Cleared
Senior-level medical device consulting for product development, FDA regulatory strategy, and post-acquisition engineering, from a trusted California-based expert.
Where Deep Expertise Meets Practical Results
Four focused practice areas, each built on decades of hands-on experience in the medical device industry.
Medical Device Product Development
From early-stage concept through design verification and validation, I guide device and instrument programs with the rigor they demand. Whether you're developing a novel implant, a robotic system, or a diagnostic device, I bring the engineering depth to move your program forward, on time and on spec.
FDA Remediation & Audit Readiness
I help teams develop and verify effective CAPAs and prepare clear 483 responses tied to design and engineering root causes, then strengthen design controls and risk management so the same gap doesn't reopen.
FDA Submission Engineering
Navigating an FDA submission takes strong engineering evidence, not just paperwork. I identify which product features and performance data support your predicate argument, build the technical evidence behind your submission, and review the final package your regulatory team sends to FDA.
Post-Acquisition Engineering
When a private equity firm or large medtech company acquires a device business, the engineering integration is often where value is made or lost. I provide the technical leadership to assess, stabilize, and optimize acquired product lines, ensuring continuity, compliance, and commercial readiness.
About Atma V LLC
A Trusted Partner, Not Just a Consultant
With deep roots in the medical device ecosystem and decades of experience across orthopedics, regulatory affairs, and post-acquisition engineering, I've built a practice on one principle: give clients the same counsel I'd give a close colleague. Atma V LLC works with startups, established OEMs, and private equity firms who need a senior technical voice they can rely on.
Ready to Move Your Program Forward?
Whether you're at the whiteboard or preparing for submission, let's talk about where I can add the most value.