Let's find the right help for your regulatory need
MDR, IVDR, UDI, EUDAMED registration. We take the time to understand what is actually blocking you, then point you to the people who can unblock it. On quote.
What we hear
Where a regulatory question stalls
Three sentences we hear on almost every first call.
We do not know where to start
The text is clear about the obligation, far less clear about the path for your particular device.
Our PRRC is on their own
One person carries compliance, with no relay when the volume climbs.
Finding the right person takes weeks
Recommendations travel by word of mouth, with no verifiable directory behind them.
How we work
Three steps, together
No self-serve service to trigger: we scope, we introduce, we follow through.
Scoping
A first conversation about your device, its class and the deadline that is pressing on you.
Introductions
We point you to the profiles that fit, or take the subject on ourselves when it is a question about EUDAMED data.
Follow-through
We stay the point of contact and adjust with you as the file moves.
Scope
What we do together, and what we do not
Named up front, so the quote holds no surprises.
What we do together
- Scoping your need, in plain language
- Introductions to the professionals listed in our database
- The EUDAMED data work: research, verification, export
- A written summary of what was agreed
What is not included
- Certifying your device — that is a notified body's role
- Acting as your PRRC or authorised representative
- A self-serve service you trigger from your account
Our starting point
The people and the register we start from
Every introduction is drawn from the professional corpus we publish, not from a private address book.
33,877
QA/RA professionals listed
49,373
companies registered in EUDAMED
3,401,232
medical devices
Source: the EUDAMED corpus published on MD Atlas.
Tell us what is blocking you
A first conversation, no commitment. We scope it with you and quote from there.
Book a slotEvery engagement is priced on quote.