Use this non-confidential intake when you want TrueMedDevice to scope a U.S. FDA or Health Canada Product Family Evidence Pack.

You do not need to know the final classification, pathway, predicate, device class, or licence route before starting. The Evidence Pack organizes public-source candidate clues for qualified RA/QA or consultant review — never a regulatory determination.

Non-confidential intake — Market-Entry Product Evidence Pack scoping

Submit product information for scoping

Begin product-family scoping for the Market-Entry Product Evidence Pack.

Share a non-confidential product description. We’ll use it to prepare a preliminary product-family profile and schedule a short scoping call before any full Market-Entry Product Evidence Pack is prepared.

The preliminary product-family profile is an internal scoping module — a candidate-review document for qualified RA/QA or consultant review, not a classification, product-code, pathway, licence eligibility, safety, effectiveness, compliance, or approval determination.

Standard scope. Standard pricing covers one product family, one jurisdiction, and one primary intended-use direction, based on non-confidential product information and public sources. Complex multi-product families, multiple intended-use directions, software-heavy products, IVDs, combination-product questions, or expanded competitor / technical comparisons are scoped separately.
One scoping intake = one product family + one jurisdiction.
FDA and Health Canada are prepared separately.
First delivery is a human-reviewed source-backed Product Evidence Pack.
Follow-up support builds on the same source-backed Product Evidence Base.
Non-confidential intake. Do not submit trade secrets, unpublished test data, source code, proprietary design files, patient data, clinical records, or confidential technical files through this public form. If your request appears to require confidential material, we will ask you to use a separate controlled process before review begins.

Report language preference

Reports are prepared from English-language official and public sources. English remains the canonical source-backed report language. If requested, TrueMedDevice can provide a companion Chinese or Japanese version to help founders, manufacturers, or internal teams review the evidence more easily.

The companion version is for internal review only — it does not replace the English source-backed report and is not the official deliverable.

TrueMedDevice does not determine classification, submission pathway, substantial equivalence, licence eligibility, safety, effectiveness, compliance, or approval outcome. We organize public-source evidence and review points for qualified RA/QA or consultant review. Evidence organized. Judgment stays with RA/QA.

1. Who is asking
2. Product family identity
3. Intended use and use context
4. Technology characteristics

Pick every characteristic that applies. Selections drive the candidate standard buckets, public safety-signal search tasks, and review point categories on the admin research surface — they do not determine classification.

Software / UI / Workflow

Clinical / Safety Mechanism

Physical / Material / Process

Regulatory / QMS Sensitivity

0 characteristics selected.

5. Existing regulatory and market context (all optional)
6. Evidence and review needs

Tick the surfaces that should appear in your Product ID Evidence Pack. Final scope is finalized after manual review.

Regulatory translation & pathway research

Similar products & public safety signals

QMS foundation & review point hooks

Delivery format

0 evidence needs selected.

7. Open context (all optional)
8. Consent and boundary

By submitting, you agree we may email you a follow-up about this Product ID intake. TrueMedDevice provides source-backed evidence organization and research support; final regulatory, legal, and QMS decisions remain with your qualified RA/QA team.

What happens after submission

  1. Submit non-confidential product information using the form above.
  2. Receive a preliminary product-family profile — a candidate-review document, not a regulatory determination.
  3. Book a 15–20 minute scoping call so we can understand your product, target market, and market-entry stage.
  4. Confirm FDA / Health Canada scope, pricing, and delivery timeline after the scoping call.
  5. Receive the source-backed Market-Entry Product Evidence Pack prepared for qualified RA/QA or consultant review.

TrueMedDevice does not determine classification, submission pathway, substantial equivalence, licence eligibility, safety, effectiveness, compliance, or approval outcome. We organize public-source evidence and review points for qualified RA/QA or consultant review. Evidence organized. Judgment stays with RA/QA.

Pilot pricing

Founder-led pilot pricing — scope confirmed after a short scoping call.

First pilots are founder-led so we can understand the product context before preparing the pack. Final price and delivery timeline are confirmed after a 15–20 minute scoping call. All prices are in U.S. dollars (USD).

  • U.S. / FDA Market-Entry Product Evidence Pack
    from US$1,800

    3–5 business days after scope confirmation

  • Canada / Health Canada Market-Entry Product Evidence Pack
    from US$1,500

    3–5 business days after scope confirmation

  • Ongoing Product Evidence Base support

    Cadence and scope discussed during the scoping call.

    Pilot pricing after first pack

We are currently accepting a small number of founder-led pilot customers. The goal is to understand your product context, deliver a useful first Market-Entry Product Evidence Pack, and learn whether ongoing source-backed Product Evidence Base support would help your team.

Standard scope. Standard pricing covers one product family, one jurisdiction, and one primary intended-use direction, based on non-confidential product information and public sources. Complex multi-product families, multiple intended-use directions, software-heavy products, IVDs, combination-product questions, or expanded competitor / technical comparisons are scoped separately.

Book a 15–20 minute scoping callDownload the evidence pack overview

Scoping calls are short and used to confirm scope, price, and delivery timeline. No payment is collected before the scoping call.

Submit product information for scoping — TrueMedDevice | TrueMedDevice