The first PMS build moment
Picture the founder in the first quality management system design session after launch planning begins. PMS sounds like a regulation, but the team needs to know what to build on Monday morning.
The first move is not to declare whether the signal raises safety, compliance, reportability, equivalence, or exposure questions. The useful move is to map source checks, record destinations, owners, cadence, and qualified-review decisions.
First PMS workflow map
| Workflow layer | Question to answer |
|---|---|
| Source check | Which public regulator, customer, complaint, service, supplier, clinical, or distributor source is checked? |
| Internal record | Which complaint, CAPA, risk, PMS, supplier, service, labeling, or management-review file receives the note? |
| Owner | Who performs the check and who reviews escalation? |
| Cadence | How often is the source checked and when is it escalated? |
| Boundary | Which conclusions remain with qualified reviewers? |
What good looks like
The result should be a simple build order for sources, owners, review cadence, escalation records, and qualified-review questions.
If the first pass finds gaps, that is useful. It shows where PMS is still only a document name and where the operating workflow needs records.
Source ledger
What it can tell you
Public FDA recall and early-alert records that can feed a first PMS source-check workflow.
What it cannot decide
Whether one manufacturer has completed PMS, complaint, CAPA, reporting, or risk-file obligations.
What it can tell you
Canadian public recall and safety-alert records that can frame one source family in a PMS workflow.
What it cannot decide
Whether one company's Canadian PMS process, importer process, or distributor process is sufficient.
What it can tell you
European medical-device sector context that can frame EU postmarket evidence questions.
What it cannot decide
Whether a manufacturer's PMS, PMCF, vigilance, clinical, or conformity evidence is sufficient.
Frequently asked questions
Is postmarket surveillance only a regulatory document?
No. It should become an operating workflow that connects external sources, internal records, owners, cadence, escalation, and qualified-review decisions.
What should a founder build first?
A source-and-record map: monitored sources, internal record destinations, owner cadence, escalation thresholds, and open reviewer decisions.
Need a first PMS workflow map?
Send the product family, markets, and current source list. We can scope a source-backed first PMS workflow checklist for qualified review.
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