FAQ

Straight answers about our process, CE/FDA checks and what to expect. Imagery is illustrative.

Are you tied to any OEM?

No. We disclose any commissions and present at least two options where feasible.

What do you verify for CE?

DoC, NB certificate/self‑declaration basis, risk management, clinical evidence, labeling/UDI.

And for FDA?

510(k) or registration status and labeling consistency. We note import responsibilities.

How fast is the shortlist?

About 10 business days from a signed brief.

Do you install/train?

We coordinate OEM training and ensure it’s included in the terms.

Service & spares?

We request spare kits and escalation contacts up front and bake them into the PO.

Frequently asked questions

Answers about our scope, independence and methodology.

Are you affiliated with manufacturers?

No. We’re independent and vendor‑neutral. No kickbacks or hidden commissions. Any potential conflicts would be disclosed in writing.

Do you provide legal or regulatory advice?

No. We review documentation and public listings to verify regulatory status for shortlisted devices. This informs your decision; it’s not legal advice.

How long does selection take?

For a single indication, a shortlist is 7–10 days after discovery. Due diligence and negotiation support typically add 1–3 weeks depending on vendor response.

Can you help with training and launch?

Yes—onboarding plan, protocol outline, safety checklists and a simple launch calendar aimed at reaching usable capacity faster.

What if we already have quotes?

We’ll benchmark and normalise them, then highlight differences in service, consumables and terms so you can negotiate confidently.

What if we pause after starting?

Scopes are staged. If you pause after Starter, your fee can be credited towards a higher scope within 30 days.

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