Fractional Regulatory Affairs Leadership for Medical Device Companies
Wayfinder Advisory helps Class I/II device companies build FDA-ready compliance infrastructure — from first regulatory hire to full quality management system buildout.
Why Wayfinder
With 20+ years in medical device regulatory affairs, Christie Trilla has repeatedly stepped in as a company’s first regulatory hire — turning regulatory complexity into sequenced, executable programs that reduce enforcement risk and open the door to market access. Wayfinder Advisory brings that same first-hire discipline to companies on a fractional or project basis.
How I Can Help
FDA Submissions & Predicate Strategy
510(k) strategy, establishment registration, device listing.
QMS Development
ISO 13485 / 21 CFR 820 buildout, CAPA, audit prep.
UDI/GUDID & Labeling
GS1 program setup and label gap remediation.
Risk Management & Sterilization
ISO 14971, AAMI ST98 / ISO 17664 support.
eQMS & Global Strategy
Platform evaluation and international market entry.
Ready to build a compliance program that scales?
Let’s talk about where your regulatory program stands today — and what it needs next.