Market-Entry Product Evidence Pack — One-page overview
What is inside a Market-Entry Product Evidence Pack?
A source-backed evidence pack prepared around your product family before you enter the U.S. or Canadian medical device market. The first pack also becomes the starting point for a reusable Product Evidence Base for later RA/QA, consultant, PMS, complaint, risk, labeling, CAPA, supplier, and inspection-readiness questions.
All prices in U.S. dollars (USD). U.S. pack from US$1,800. Canada pack from US$1,500.
The evidence pack, organized around your product family
Twelve evidence layers, all anchored to one product family and one jurisdiction (FDA or Health Canada). The same structure is reused as the Product Evidence Base grows.
Center
Your product family
Regulator-language product profile
Intended use, user / patient / environment, technology characteristics — stated in FDA / Health Canada regulatory language.
Direct & indirect similar-product comparison
Direct and indirect similar products from public regulator data plus public company materials. Same/different comparison against your product.
FDA / Health Canada public records
510(k), De Novo, PMA, FDA registration, MDALL, licence records — company name, product name, regulatory record IDs.
Company sites, IFUs, manuals, brochures, public technical materials
Public company / product pages, instructions for use, manuals, brochures, labels, and publicly available technical materials enriching the comparison where available.
Candidate pathway / class / product-code review clues
Candidate product-code, regulation, class, 510(k) / De Novo / PMA / 510(k)-exempt, or Pre-Submission discussion points for qualified review.
Official forms / fees / review timelines
FDA forms, eSTAR references, user fees, and public review-timeline references where available. Health Canada forms and fee references for the Canada pack.
Guidance & recognized standards review points
Applicable public guidance and recognized-standard / ISO review points relevant for qualified RA/QA or consultant discussion.
Public safety history
Recalls, MAUDE themes, warning letters, safety communications, Health Canada advisories, enforcement / field-action themes where relevant.
Preparation gap checklist
Practical gap checklist: information, testing, documentation, labeling, software, risk, usability, biocompatibility, sterility, electrical safety, cybersecurity, clinical, or performance evidence to discuss or prepare.
Source ledger
Record IDs, source links, access dates, and a short note on why each source matters — so any reviewer can re-walk the evidence trail.
RA/QA & consultant review questions
Candidate review-point library structured for qualified RA/QA or consultant discussion. Includes a short consultant briefing sheet.
Reusable Product Evidence Base for lifecycle decisions
The same source-backed context is brought back to later complaints, design changes, labeling updates, CAPA screening, risk-file updates, PMS reviews, supplier signals, standards updates, and inspection-readiness discussions.
U.S. / FDA pack
from US$1,800
3–5 business days after scope confirmation
- ›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/product materials where available
- ›Same/different comparison between your product and similar products
- ›Public technical-characteristic comparison where available
- ›Official FDA forms / fees / eSTAR / guidance / recognized-standards checklist where applicable
- ›Practical preparation gap checklist
- ›Public safety-history scan: recalls, MAUDE themes, warning letters, safety communications, enforcement or field-action themes where relevant
- ›Source ledger with record IDs, source links, access dates, and why each source matters
- ›Candidate review-point library for RA/QA or consultant discussion
- ›Consultant / RA/QA briefing sheet
- ›Clear limitations and unanswered questions
Canada / Health Canada pack
from US$1,500
3–5 business days after scope confirmation
- ›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 and public company/product materials where available
- ›Same/different comparison between your product and similar products
- ›Public technical-characteristic comparison where available
- ›Official Health Canada forms / fees / guidance / standards checklist where applicable
- ›Practical preparation gap checklist
- ›Public safety-history scan: recalls, advisories, incident themes, safety communications, or public field-action themes where relevant
- ›Source ledger with record IDs, source links, access dates, and why each source matters
- ›Candidate review-point library for RA/QA or consultant discussion
- ›Consultant / RA/QA briefing sheet
- ›Clear limitations and unanswered questions
Why this becomes more valuable over time
The first Market-Entry Product Evidence Pack is the starting point for a source-backed Product Evidence Base around the customer’s product family. When the team later faces a complaint, product change, labeling update, CAPA screening, risk-file update, PMS review, service issue, supplier signal, standard update, consultant question, or inspection question, the relevant product-specific sources and prior review context can be brought back to the decision point.
This helps avoid open-loop quality decisions where an issue is closed as “human error” or “retraining complete” without reassembling the relevant product evidence, prior complaints, CAPA history, risk assumptions, labeling/usability signals, similar-product safety history, and applicable standards/guidance.
- ›When a new complaint appears, the evidence base helps retrieve similar prior complaints, public similar-product safety signals, risk-file review points, labeling / usability concerns, and candidate CAPA screening questions.
- ›When a standard or guidance changes, the evidence base helps identify which product-specific review points may need to be revisited.
- ›When the responsible person changes, the product evidence context does not disappear with the person. The next RA/QA reviewer can see the prior source trail, review questions, decisions, and unresolved gaps.
- ›When an inspection question arises later, the company has a clearer record of what evidence was reviewed and why a decision was made.
Evidence organized. Judgment stays with RA/QA.
TrueMedDevice does not determine final classification, pathway, licence eligibility, substantial equivalence, safety, effectiveness, compliance, approval likelihood, or regulatory outcome. We prepare source-backed evidence, source ledgers, candidate review points, and briefing materials to support qualified RA/QA, consultant, and company review.
Use the pack effectively
The Product Evidence Pack supports — but does not replace — qualified RA/QA or regulatory consultant judgment. If you are preparing for a first consultant meeting, the eight-block checklist below covers what to bring.