The CEO problem
Picture the CEO in an expansion planning meeting before distributors are selected. The commercial team wants to promise market coverage, but RA/QA has not yet shown which PMS evidence, owners, and review triggers each jurisdiction needs.
The right first move is not to declare whether the signal raises safety, compliance, reportability, equivalence, or exposure questions. The useful move is narrower: map the public signal to the product family, identify missing evidence, and prepare the questions qualified reviewers must answer.
Global PMS readiness map
| Map layer | Question to answer |
|---|---|
| Market | Which jurisdiction or commercial launch plan triggered the review? |
| Public source | Which regulator, database, recall source, or guidance page frames the question? |
| Internal record | Which complaint, CAPA, risk, supplier, label, service, or management-review record connects to the signal? |
| Owner | Who validates the evidence and writes the next qualified-review question? |
| Boundary | Which conclusions remain with RA/QA, legal, clinical, regulatory, quality, or leadership reviewers? |
Where teams overclaim
A public recall in one jurisdiction does not automatically answer a distributor question in another jurisdiction. A useful global PMS file keeps source scope, jurisdiction, internal evidence, and qualified-review decisions visible.
The file should help the CEO see what is known, what is missing, and which market promise should wait for review.
Source ledger
What it can tell you
United States public recall and early-alert records that can create product-family monitoring questions.
What it cannot decide
Whether a specific company's device is reportable, compliant, safe, effective, or exposed.
What it can tell you
Canadian recall and safety-alert records that can be linked to product-family or distributor review questions.
What it cannot decide
Importer duties, distributor duties, field-action obligations, or complaint dispositions for a specific company.
What it can tell you
European public medical-device sector resources and implementation context that may frame EU-facing PMS questions.
What it cannot decide
Whether one manufacturer's PMS plan, PSUR, PMCF, clinical evidence, or conformity file is acceptable.
Frequently asked questions
Can one PMS map support more than one market?
Yes, if the map keeps jurisdiction labels, source limits, internal evidence owners, and qualified-review decisions separate.
What is the first useful output?
A global PMS readiness map with source links, jurisdiction labels, internal owner assignments, missing evidence, and next review questions.
Need a PMS map before making market promises?
Send the product family, target markets, and current expansion question. We can scope a source-backed readiness map for qualified review.
Reader feedback
Useful pages should feed the next topic choices. Leave a signal or a short comment.