Cardiovascular device regulatory consulting
From first‑in‑human to market.
Regulatory strategy, FDA submissions and US clinical programs for medical device startups.
The US pathway for a Class III cardiovascular device
What we do
Six things, all on the US pathway. Each one is done by the people you meet, not handed down.
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.
Why a focused firm
Cardiovascular devices. The US pathway. Nothing else.
Large consultancies take startup work and staff it junior. Registration agents file paperwork and have no clinical depth.
We work only on cardiovascular devices and only with FDA. The people who write your submission are the people who answer the agency on your behalf.
Experience
Class III, first-in-human, with FDA.
We have significant experience taking Class III cardiovascular devices through IDE with FDA, the clinical stage on which a PMA is ultimately built.
- Pre-Submission strategy and Early Feasibility Study application for a Class III cardiovascular implant
- Response to FDA deficiency feedback on behalf of the sponsor
- Site budget and clinical trial agreement negotiation at leading US academic cardiac centers
- Investigational device import and customs coordination
Where programs lose time
Three mistakes we see first-time sponsors make.
The pathway is assumed.
Classification and predicate questions get settled by hope, then by a deficiency letter. A pathway review settles them on paper first.
The Pre-Submission is skipped.
Bench testing starts before anyone asks FDA what it will accept. The test plan is then redone with the clock running.
Sites are chosen before contracts.
Budgets and clinical trial agreements at academic centers take months. Start them with the IDE, not after approval.
Notes on the US pathway
Short explainers for sponsors preparing a first submission. All notes
- Clinical strategy
What an Early Feasibility Study asks of a first-time sponsor
An EFS is not a small pivotal and not a shortcut. It is a bargain with FDA: less complete data now, in exchange for a sponsor who shows it understands the risk.
- Quality systems
QMSR is in force. What changes for a small manufacturer
The 21 CFR 820 you remember is not the 21 CFR 820 an investigator will inspect against. What actually changed, and why startups are the most exposed.
- Submissions
Reading a deficiency letter: what FDA is actually asking
A deficiency letter is not a rejection. It is the agency telling you, in order, exactly what stands between your submission and a decision.
Tell us where your program is.
We reply within 12 hours. You get a written scope and estimate before any work starts.