Pre-production brief
| Field | Answer |
|---|---|
| Reader | Founder or first RA/QA hire preparing market-entry risk and comparator review. |
| Trigger | A consultant, investor, distributor, or customer conversation is coming and the safety-history sources have not been checked. |
| Blocked decision | Which public safety signals should be reviewed before the market-entry story is locked. |
| Useful artifact | Dated safety-history scan packet with source links, themes, absence boundaries, and owner questions. |
Reviewer workflow
- Define the product family, candidate product codes, device names, manufacturers, and date window before searching.
- Check FDA recalls, MAUDE, warning letters, and safety communications for repeated themes.
- If Canada is in scope, check Health Canada recalls and safety alerts separately from FDA records.
- Record absence claims carefully: source searched, terms used, date checked, and known limits.
- Route safety, reportability, risk acceptability, labeling, and launch-readiness questions to qualified reviewers.
What to do with recurring themes
Recurring public issues can shape design-control, labeling, risk-management, post-market surveillance, customer-training, and distributor questions. They should not be converted into a blanket conclusion about your device.
The scan should make themes visible enough for review: source, date, device family, issue category, severity language where published, and owner follow-up.
What TrueMedDevice can prepare
TrueMedDevice can prepare the public safety-history source ledger, search log, theme table, absence-claim notes, and owner question list for qualified review.
Source ledger
What it can tell you
FDA public recall and correction context for device families and named products.
What it cannot decide
Safety, risk acceptability, compliance, or saleability for a specific product.
What it can tell you
Public adverse-event report records for search terms, manufacturers, devices, and time windows.
What it cannot decide
Causality, event rate, clinical risk, or reportability for a specific company.
What it can tell you
Public warning-letter language that may surface compliance or quality-system themes.
What it cannot decide
Whether your company has the same issue or whether enforcement risk applies.
What it can tell you
FDA public safety communications relevant to device categories or technologies.
What it cannot decide
Whether a specific device is safe, effective, or acceptable for market entry.
What it can tell you
Canadian public recall and safety-alert records that may affect market-entry review.
What it cannot decide
Canadian licence sufficiency, saleability, risk acceptability, or compliance status.
Frequently asked questions
Does a safety-history scan prove my product is safe?
No. It organizes public safety-history signals and gaps. Safety, risk acceptability, and compliance require qualified review.
Why include both FDA and Health Canada sources?
The sources are different. If Canada is in scope, Health Canada recalls and safety alerts should be checked separately from FDA records.
Can absence of search results be used as a claim?
Only with caution and review. The packet should document source, query, date, and limits rather than claiming no risk exists.
Need a safety-history scan before the next market-entry review?
TrueMedDevice can organize public safety-history sources, repeated issue themes, absence boundaries, and owner questions into one review packet.
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