Services
What we do
Six things, all on the US pathway for a cardiovascular device. Each one is done by the people you meet, not handed down. Every scope starts with a written estimate.
Pre-Submission
Fix the pathway before you spend on evidence.
Submissions
IDE, EFS, 510(k), De Novo, PMA pathway.
FDA correspondence
We answer the agency on your behalf.
Clinical programs
Sites, budgets, agreements, IRB, start-up.
Quality systems
ISO 13485, 21 CFR 820, QMSR, audit readiness.
Import and customs
Investigational device shipments and entry documentation.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.