Market-Entry Product Evidence Packs for U.S. and Canadian medical device launches
Source-backed product evidence packs for founders, manufacturers, RA/QA teams, and consultants. We organize the evidence surface — regulator-language product profile, direct and indirect similar-product comparison, official forms / fees / guidance / standards, preparation gap checklist, public safety-history themes, and a source ledger.
U.S. from US$1,800 · Canada from US$1,500 · all prices in U.S. dollars (USD)
Evidence organized. Judgment stays with RA/QA.
from US$1,800
3–5 business days after scope confirmation
U.S. / FDA Medical Device Market-Entry Product Evidence Pack
Before you enter the U.S. medical device market, get a source-backed view of your product family and how it compares with similar products already in the market. We organize direct and indirect similar-product comparison, candidate product-code / regulation / class / pathway clues, FDA forms / fees / eSTAR / guidance / recognized standards, a practical preparation gap checklist, public safety-history themes, and a source ledger.
- ›FDA-style product regulatory-language profile
- ›Candidate product code / regulation / class / pathway clues (510(k), De Novo, PMA, 510(k)-exempt, Pre-Submission discussion points)
- ›Direct and indirect similar-product comparison from FDA public data + public company / IFU / manual / brochure / technical materials
- ›Same / different comparison vs. your product, with public technical-characteristic differences where available
- ›Official FDA forms / fees / eSTAR / guidance / recognized standards checklist
- ›Practical preparation gap checklist + public FDA review-timeline references
- ›Public safety-history scan: recalls, MAUDE themes, warning letters, safety communications, enforcement / field-action themes
- ›Candidate review-point library for design / risk / verification / usability / labeling / cybersecurity / PMS
- ›Source ledger (record IDs, links, access dates)
- ›Consultant / RA/QA briefing sheet + clear limitations and unanswered questions
from US$1,500
3–5 business days after scope confirmation
Canada / Health Canada Medical Device Market-Entry Product Evidence Pack
Before you enter the Canadian medical device market, get a source-backed view of your product family and how it compares with similar licensed devices already in the Canadian market. We organize direct and indirect similar-product comparison from MDALL, candidate Class I / II / III / IV clues, Health Canada forms / fees / guidance / standards, a preparation gap checklist, public safety-history themes, and a source ledger.
- ›Health Canada-style product regulatory-language profile
- ›Candidate Class I / II / III / IV clues, medical device licence / MDEL discussion points
- ›Direct and indirect similar-product comparison from MDALL + public company / IFU / manual / brochure / technical materials
- ›Same / different comparison vs. your product, with public technical-characteristic differences where available
- ›Official Health Canada forms / fees / guidance / standards checklist
- ›Practical preparation gap checklist + public Health Canada review-timeline references
- ›Public safety-history scan: recalls, Medical Device Problem Reports, advisories, incident themes, field-action themes
- ›Candidate review-point library for design / risk / verification / usability / labeling / cybersecurity / PMS
- ›Source ledger (record IDs, links, access dates)
- ›Consultant / RA/QA briefing sheet + clear limitations and unanswered questions
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.
TrueMedDevice research packs are source-backed evidence organization services, not regulatory, legal, or compliance advice. TrueMedDevice does not determine device classification, submission pathway, substantial equivalence, licence eligibility, safety, effectiveness, compliance, or approval outcome. All findings are candidate review clues for qualified RA/QA professionals or regulatory consultants. Evidence organized. Judgment stays with RA/QA.
What every new medical device needs researched before market entry
For each new medical device product, someone has to translate product facts into FDA or Health Canada language, review classification or licence clues, gather official forms / fees / guidance references, compare similar public products, scan public safety history, and prepare questions for a qualified consultant conversation. TrueMedDevice organizes that work into a source-backed Product Family Evidence Pack.
U.S. FDA Market-Entry Product Evidence Pack
Source-backed FDA market-entry research — from US$1,800.
Open FDA packHealth Canada Market-Entry Product Evidence Pack
Source-backed Health Canada licence research — from US$1,500.
Open Health Canada pack
Explore the Medical Device Product Evidence Map
Start with the device. Then map the public evidence around it. The product-centered Evidence Map organizes similar-device records, classification clues, licence clues, safety history, guidance clues, and candidate review points for U.S. FDA and Health Canada market-entry research.
Open the Product Evidence Map