Regulatory Expertise

I help medical device companies align engineering execution with regulatory expectations. My work spans software lifecycle compliance, risk management, cybersecurity, design controls, verification planning, and documentation systems that support FDA and international submissions. I bridge the gap between technical development and regulatory requirements, ensuring teams build devices that are both safe and submission‑ready.

IEC 62304 Software Lifecycle

Deep experience applying IEC 62304 across embedded systems, multi‑processor architectures, clinical research tools, and application‑level software. I help teams interpret the standard pragmatically and implement processes that scale.

Capabilities

• Software development plans (SDP)
• Software requirements (SRS) and architecture (SDD)
• Software unit, integration, and system verification planning
• Traceability across requirements, risks, and tests
• Software classification and lifecycle documentation
• Automated verification tools and simulators

ISO 14971 Risk Management

Hands‑on experience performing hazard analysis, software FMEA, system FMEA, and risk‑based decision making for Class I, II, and III devices — including critical care, surgical, and implant‑adjacent systems.

Capabilities

• Hazard analysis and risk identification
• Software FMEA (SFMEA) and system FMEA (DFMEA)
• Risk control definition and verification
• Risk traceability and documentation
• Risk‑based decision frameworks for engineering teams

Cybersecurity & Threat Modeling

Support for cybersecurity analysis, threat modeling, and documentation aligned with FDA expectations for networked, cloud‑connected, and wearable devices.

Capabilities

• Cybersecurity risk assessments (CSRA)
• Threat modeling and attack surface analysis
• Software bill of materials (SBOM) support
• Open‑source software review and licensing checks
• Security‑related verification and documentation

Design Controls & Documentation Systems

Ensuring engineering, quality, and regulatory teams work from a unified, compliant documentation system that supports audits and submissions.

Capabilities

• Design control implementation and coaching
• DHF and technical file development
• Requirements and interface clarity
• Trace matrices and documentation workflows
• Audit‑ready documentation systems

ISO 13485 & QMS Support

Experience building and improving QMS systems for startups and established manufacturers, including SOP creation, configuration management, coding standards, and process templates.

Capabilities

• QMS gap analysis and remediation
• SOP development (software lifecycle, configuration mgmt, coding standards)
• Document control and quality manual support
• Process development for startup‑to‑scale transitions
• Internal audit preparation and documentation cleanup

Verification & Validation Planning

Support for V&V strategy, protocol development, automated test systems, and hardware‑in‑the‑loop verification — especially for complex, safety‑critical devices.

Capabilities

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

Submission‑Ready Deliverables

I support teams preparing for 510(k), De Novo, and international submissions by ensuring engineering documentation is complete, consistent, and aligned with regulatory expectations.

Capabilities

• SRS, SDD, architecture, and interface documentation
• Risk management files
• Verification protocols and reports
• Trace matrices and lifecycle documentation
• Cybersecurity documentation
• QMS and SOP support

Let’s Talk

If you need engineering‑driven regulatory support, lifecycle alignment, or submission‑ready documentation, I can help.