When Compliance Can’t Wait – We Deliver.
TruNorth Quality & Regulatory Solutions provides senior-level compliance expertise to medical device companies that need results—not delays. Warning letters, audits, CAPAs, recalls, and QMS builds handled with precision and speed.
What We Offer
Medical Device Startups
Class I & II companies building their first FDA-compliant QMS — done right the first time.
Growth-Stage Manufacturers
Preparing for your first FDA or MDSAP inspection or ISO 13485 certification with senior-level support.
Companies Under FDA Scrutiny
Warning letters, 483s, consent decrees — deadline-driven remediation with proven results.
Manual Process Companies
Still running on spreadsheets and paper? We modernize your quality systems for scale and sustainability.
What We Do
Warning Letter & 483 Response
FDA-defensible responses drafted
Audit & Inspection Readiness
Mock audits, gap assessments, QSIT preparation, and day-of support.
QMS Build & Remediation
SOPs, CAPA programs, design controls, and QMSR transition support.
20+ Years. Zero Guesswork.
With two decades of hands-on experience at the world’s leading medical device companies, TruNorth brings senior-level regulatory expertise to every engagement. We don’t send junior consultants. You get direct access to someone who has managed FDA inspections, closed warning letters, and built quality systems that hold up under scrutiny.
Why TruNorth
FDA-Specialist
We focus exclusively on FDA-regulated medical device companies. No generalists. No learning curve.
Professional
Every engagement is hand-on with consultants over 20+ years
Results-Driven
We don’t bill hours for the sake of billing. Every engagement has a defined scope, deliverable, and outcome.