Quality Management System Development
Building a new QMS or bringing an existing one into compliance with 21 CFR Part 820/QMSR and ISO 13485. This covers document control, CAPA procedures, training records, supplier controls, and the management activities that FDA inspectors and notified bodies look for.
Regulatory Inspection Readiness
Mock inspections, gap assessments, and preparation sessions for inspections and audits. Draws directly on ten years of experience at CDRH across pre-market and post-market functions.
Process Improvement (Lean Six Sigma)
Applying Lean Six Sigma and Agile methods to regulatory and operational processes, reducing cycle times, cutting waste, and removing bottlenecks that slow down submissions, complaints, and CAPA closures. Certified Master Black Belt, facilitated the team that reduced the time for Early Alerts for potential Class I Recalls from 30 to approximately 10 days.
Software Quality and Digital Health
Quality assurance for software as a medical device (SaMD), including IEC 62304 software lifecycle compliance, design controls, and verification and validation. Background includes establishing CDRH’s first digital health team and leading the only FDA software group certified to ISO 9001:2015.