Services

I help medical device companies deliver safer, clearer, and more predictable development outcomes through engineering leadership, software architecture, regulatory alignment, verification planning, and process improvement. My work bridges the gap between technical execution and regulatory expectations.

Medical Device Project Leadership

Hands‑on leadership for complex, cross‑functional development programs across software, hardware, firmware, clinical, and regulatory teams.

What’s Included

• Planning & execution across SW, HW, FW, ID, and clinical research
• Cross‑functional alignment and communication
• Milestone, deliverable, and dependency management
• Risk‑based decision making and escalation support
• Stakeholder communication and technical leadership
• Development under FDA, IEC, and ISO constraints
• Support for Class I, II, and III devices

Outcomes

• Predictable execution and delivery
• Clear ownership and accountability
• Reduced development friction
• Stronger cross‑team communication
• Aligned engineering and regulatory expectations

Software Architecture & Development Support

Expert guidance for embedded, multi‑processor, and application‑level medical device software — including verification tools, simulators, and clinical research systems.

What’s Included

• Architecture review & definition for embedded and application software
• Requirements, interfaces, and system clarity
• Design documentation (SRS, SDD, architecture, interfaces)
• Traceability & lifecycle alignment (62304)
• Automated verification tools and simulators
• Coaching engineering teams on regulated development

Outcomes

• Cleaner, more maintainable architecture
• Faster development and integration
• Fewer defects and clearer interfaces
• Documentation that supports audits & submissions

Regulatory & Compliance Alignment

Ensuring engineering, quality, and regulatory teams work from the same playbook — with documentation and processes that stand up to FDA and notified body scrutiny.

What’s Included

• IEC 62304 software lifecycle alignment
• ISO 14971 risk management (SFMEA, DFMEA, hazard analysis)
• Cybersecurity analysis & threat modeling
• QMS SOP development (ISO 13485, configuration mgmt, coding standards)
• Verification & validation planning
• DHF / technical file support
• Trace matrix creation and maintenance

Outcomes

• Audit‑ready documentation
• Reduced regulatory friction
• Clear, consistent, compliant processes
• Confidence in submission‑ready deliverables

Verification, Validation & Test Systems

Building the tools, protocols, and infrastructure needed to verify complex medical devices — including automated test systems and hardware‑in‑the‑loop setups.

What’s Included

• System V&V planning and protocol development
• Automated verification tools and simulators
• Hardware‑in‑the‑loop test systems
• Alarm testing, corner‑case testing, and fault insertion
• Traceability and requirements coverage
• Bench‑top device simulation tools

Outcomes

• Higher test coverage
• Faster verification cycles
• Reduced defects and integration issues
• Submission‑ready V&V documentation

Process Improvement & Team Coaching

Helping teams work smarter, communicate better, and deliver more predictably — especially in fast‑moving or scaling environments.

What’s Included

• PM training (based on PMI principles)
• Documentation workflows & design control clarity
• Requirements development & interface definition
• Engineering/quality/regulatory collaboration
• Startup‑to‑scale process development
• QMS gap analysis and remediation

Outcomes

• Stronger, more aligned teams
• Better communication and fewer surprises
• Faster development cycles
• Less rework and clearer documentation

Let’s Talk

If you need leadership, clarity, or structure in your medical device development, I can help.