Services

Four Practice Areas. One Trusted Partner.

Deep, focused expertise across the full medical device development and commercialization lifecycle, from concept through cleared and beyond.

Devices & Instruments

Medical Device Product Development

From early-stage concept through design verification & validation to Market Launch, I guide device and instrument programs across implants, robotics, diagnostics, and surgical consumables, with the rigor they demand.

What's Included

Concept development and design input definition across implants, instrumentation, robotics, diagnostics, and surgical consumables
Design history file (DHF) structure and documentation strategy
Design verification and validation (V&V) planning, test protocol development, and execution oversight
Surgical instrument design and usability engineering
Material selection, biocompatibility strategy, and supplier qualification
Risk management per ISO 14971, including FMEA and hazard analysis.
Design for manufacturability (DFM) and supplier transfer planning

Ideal For

Startups developing a first-in-class medical device, established OEMs expanding their portfolio, and PE-backed companies needing senior engineering leadership without a full-time hire.

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483s · CAPA · Root Cause

FDA Remediation & Audit Readiness

When an FDA inspection turns up a 483, or a warning letter follows, remediation is where the clock matters most.

Learn more about QMSR

What's Included

CAPA development and effectiveness verification
FDA Form 483 response strategy and drafting
Quality system remediation across design controls and risk management
Root cause analysis for recurring nonconformances
QMSR readiness and transition gap assessment

Ideal For

Companies facing an open 483 tied to a design or engineering root cause, and teams whose risk management file needs to hold up under QMSR.

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Predicate Analysis · Technical Files

FDA Submission Engineering

An FDA submission is only as strong as the engineering evidence behind it, not just the paperwork.

What's Included

Analysis of product features and performance data to identify strong predicate candidates
Engineering evidence development for substantial equivalence arguments
Technical file review and engineering content development
Design controls alignment with QMSR (21 CFR Part 820, incorporating ISO 13485:2016 by reference)
Engineering input for FDA additional information requests and deficiency letters

Ideal For

Companies whose regulatory team needs strong engineering evidence behind a submission, whether that's predicate analysis, technical file content, or a second engineering opinion before the package goes to FDA.

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M&A Integration

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.

What's Included

Technical due diligence: product line assessment, IP review, and regulatory risk identification.
Post-close engineering stabilization and continuity planning
Product line rationalization and roadmap development
Quality system gap analysis and remediation planning under QMSR (21 CFR Part 820, incorporating ISO 13485:2016 by reference).
Interim VP Engineering or Chief Engineer engagement
Supplier and contract manufacturer transition management
Distributed and offshore engineering team leadership, including hiring, training, and systems setup across multiple geographies

Ideal For

Private equity firms acquiring medtech assets, strategic acquirers integrating a bolt-on, and portfolio companies that need senior technical leadership during a transition period.

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Not sure which service fits your situation?

Most engagements start with a conversation. Tell me where you are and where you need to go. I'll tell you honestly whether and how I can help.

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