About

Senior Expertise. Practical Counsel.

I founded Atma V LLC to give medical device companies access to the kind of senior technical and regulatory guidance that's usually locked inside large organizations.

With 25 years in medical device engineering at companies like Stryker and NuVasive, building knee systems, instrumentation, and spine robotics, I've led product development programs across implants, diagnostics, wound care, and surgical consumables, from whiteboard to FDA clearance, guided companies through FDA submissions and audits, and provided the engineering leadership that PE-backed medtech acquisitions need to protect and grow their investment. I'm based in California today, working with device companies globally. I also help teams think clearly about where AI tools genuinely belong in a regulated development process, and where they don't.

My Approach

I work the way a trusted colleague would, straightforward, with your program's success as the only agenda. When I take on a project, I'm accountable for the outcome, not just the deliverable.

Depth over breadth

I focus on device engineering leadership, regulatory strategy, and post-acquisition integration, not marketing, sales, or finance work outside that lane. I don't try to be everything to everyone.

Candor over comfort

If your regulatory strategy has a gap or your design history file won't survive an audit, I'll tell you before the FDA does.

Accountability

I'm not a staff augmentation resource. I'm a partner who owns the outcome of every engagement I take on.

Areas of Expertise

Risk Management (ISO 14971)
FDA Remediation & Audit Readiness
Implant & Device Design
Surgical Instrument Development
FDA 510(k) Submissions
Design Controls: QMSR (21 CFR Part 820, incorporating ISO 13485:2016 by reference)
Technical Due Diligence
Post-Acquisition Integration
Design Verification & Validation
Submission Engineering Support
Quality System Gap Analysis

Let's Work Together

If you're looking for a senior technical partner who will give you straight answers and deliver results, I'd like to hear about your project.

Atma V LLC — medical device consulting firm logo

Expert medical device consulting for product development, FDA regulatory strategy, and post-acquisition engineering.

California, USA

Services

  • Medical Device Product Development
  • FDA Remediation & Audit Readiness
  • FDA Submission Engineering
  • Post-Acquisition Engineering

© 2026 Atma V LLC. All rights reserved.

Medical Device Consulting · California

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