Market-Entry Product Evidence Pack — U.S. & Canada
Before market entry, public regulatory information is scattered. We organize it around your product.
Founders, manufacturers, importers, and RA/QA teams preparing FDA or Health Canada market entry have to pull together public information that lives in many places: similar products and licensed devices, candidate product codes / classes / licence clues, intended-use language, official guidance, forms, fees, submission checklists, recalls, adverse events, warning letters, and safety communications.
The Market-Entry Product Evidence Pack is a source-backed research report that organizes that scattered public information around your specific product or product family — so you know what to review before speaking with a consultant, planning a submission, preparing QMS / risk / PMS starting points, or making market-entry decisions.
FDA pack from US$1,800 · Health Canada pack from US$1,500 · Status Snapshot $199
Evidence organized. Judgment stays with RA/QA.
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.
Why this report exists
The public information you need is real — and scattered.
Before market-entry work begins, founders, manufacturers, importers, and RA/QA teams typically need to understand all of the following — pulled from public FDA, Health Canada, and similar-device sources, then organized around their specific product.
What this report assembles for your product
- How the product may be described in FDA / Health Canada public sources
- Similar products or licensed devices
- Candidate product-code / class / licence clues
- Applicable guidance documents
- Official forms, fees, and submission-preparation checklists
- Public safety-history scan — recalls, adverse events, warning letters, safety communications
- Consultant-prep questions
- Risk / labeling / PMS / usability review points
- Information gaps to close before market-entry work begins
Without this organized, teams typically end up…
- Searching FDA, MDALL, MAUDE, guidance, and recall databases one tab at a time.
- Using consultant time to reconstruct public-source context that could have been organized before the call.
- Walking into consultant calls without a written product description, predicate / licensed-device shortlist, or safety-history scan.
- Treating one regulator search result as the answer instead of as one source among several.
This is research and review support. TrueMedDevice does not determine classification, submission pathway, predicate suitability, licence route, clearance or approval likelihood, compliance, or legal obligations. Those decisions stay with your qualified RA/QA team or regulatory consultant.
Pilot pricing
Founder-led pilot pricing. Scope confirmed after a scoping call.
Pricing is shown as a starting point. Final scope, price, and delivery timeline are confirmed after a short scoping call so the pack matches your product context.
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 Packfrom US$1,800
3–5 business days after scope confirmation
- Canada / Health Canada Market-Entry Product Evidence Packfrom 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.
Scoping calls are short and used to confirm scope, price, and delivery timeline. No payment is collected before the scoping call.
Two market-entry packs
FDA and Health Canada, prepared separately.
After the first pack, the source-backed Product Evidence Base is reusable for future review questions on the same product family.
U.S. / FDA Market-Entry Product Evidence Pack
From US$1,800 — founders, foreign manufacturers, and RA/QA teams preparing for U.S. market entry.
FDA-style product regulatory-language profile, candidate product code / regulation / class / pathway clues, direct and indirect similar-product comparison from FDA public data and public company materials, official FDA forms / fees / eSTAR / guidance / recognized-standards checklist, practical preparation gap checklist, public safety-history scan, source ledger, and a consultant / RA/QA briefing sheet.
View U.S. pack detailsCanada / Health Canada Market-Entry Product Evidence Pack
From US$1,500 — teams preparing Canadian Class I–IV licence review or Canada-entry planning.
Health Canada-style product regulatory-language profile, candidate Class I / II / III / IV clues, direct and indirect similar-product comparison from Health Canada public data plus public company materials, official Health Canada forms / fees / guidance / standards checklist, practical preparation gap checklist, public safety-history scan, source ledger, and a consultant / RA/QA briefing sheet.
View Canada pack detailsHow the pack is organized
The Market-Entry Product Evidence Pack, organized in four rings around your product.
This is the structure of the report itself — not a separate product. Each ring is delivered as part of the same source-backed pack, organized around the specific product or product family at the center.
Center
Your product / product family
The device, SKU, manufacturer + product, or product family you are preparing to bring to market — or that you already sell.
Ring 1
Market Identity
FDA / Health Canada market context, candidate product code / class / licence clues, intended use and product description, and the market-entry direction.
Ring 2
Public Evidence
Similar products and licensed devices, applicable guidance documents, official forms / fees / submission checklist, recalls, adverse events, warning letters, and safety communications.
Ring 3
Review Questions
Consultant-prep questions, RA/QA review points, risk / PMS / labeling / usability review points, market-entry planning gaps, and shipping / inspection / quality / supplier questions where relevant.
Ring 4
Reusable Evidence Base
Once the first pack is delivered, the source-backed product context, similar-device records, guidance / standards references, and review-point library remain available as a reusable evidence base — so the next consultant question, PMS review, labeling change, complaint, or follow-up review starts from organized context instead of from a blank search.
All four rings ship in the Market-Entry Product Evidence Pack. Ring 4 is the source-backed context the same pack leaves behind for follow-up review — not a separate product.
Non-confidential intake only.
Do not submit trade secrets, unpublished test data, source code, proprietary design files, patient data, clinical records, or confidential technical files through the public intake form. The first Product Family Profile is built from public information and non-confidential product descriptions. If your request appears to require confidential material, we will ask you to use a separate controlled process before review begins.
Smaller ways to start, and related reading
Other ways to work with us.
The Market-Entry Product Evidence Pack is the main offer. The Product Status Snapshot is a lower-friction starting point when you are not yet ready for the full report. The other items are related research and reference material.
- Product Status Snapshot — $199, 2 business days
A lower-friction starting point. One device, one manufacturer, one jurisdiction (U.S. or Canada), one source-backed PDF — for buyers, importers, supplier reviews, or quick screening before a Market-Entry Product Evidence Pack.
- Post-Clearance Review Pack
A variant of the Market-Entry pack for teams with a cleared or licensed product who want a reusable evidence baseline for PMS, complaints, CAPA screening, risk review, change review, or future market expansion.
- RA/QA Evidence Self-Check
A short, structured self-assessment your RA/QA team can run in minutes to surface decision-point evidence gaps before a review.
- Insights
Long-form writing on RA/QA decision reuse, post-market surveillance, and regulatory evidence patterns.
Start the research before the application.
Source-backed evidence, organized once, reusable for future market-entry, PMS, complaint, design-change, labeling, risk, or consultant questions.
See what the evidence pack includes
Book a 15–20 minute scoping call
Submit product information for scoping
Evidence organized. Judgment stays with RA/QA.
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.