Regulatory Strategy and Market Access
✨
510(k), De Novo, and PMA planning
CE Marking (MDR/IVDR)
Global pathways: Health Canada, TGA, PMDA, ANVISA, and more
Predicate analysis and technical file planning
Clinical evaluation mapping
Quality Management Systems
✨
QMS builds & modernization per ISO 13485
Design Control architecture
Risk Management per ISO 14971
CAPA, NCR, Post-Market Surveillance
Internal audit programs
Submission
Package
Development
✨
FDA submission categories
MDR and IVDR technical documentation
Labeling / UDIs (EUDAMED / FURLS / DRLM)
Regulatory authority liasion support
Documentation remediation
Leadership
Support
✨
Weekly governance
Cross-functional alignment
Pre-audit preparation
Program oversight
On-demand regulatory firepower
Regulatory intelligence, forecasting and risk mapping
MDSAP readiness