Pre-production brief
| Field | Definition |
|---|---|
| Reader | Founder mapping quality-system readiness for one startup device company. |
| Trigger | A manufacturer, investor, consultant, distributor, customer, or market-entry plan asks about ISO 13485 readiness. |
| Blocked decision | The team cannot tell which quality-system evidence exists, which owner controls it, and which gaps need review. |
| Useful output | An ISO 13485 readiness map with process evidence, jurisdiction prompts, source limits, and owner decisions. |
What the readiness map should include
- The trigger for the readiness question and the decision the founder must make next.
- Process evidence for document control, design control, risk management, supplier control, production, complaint handling, corrective and preventive action, and management review.
- Named owners for each evidence area and what is missing.
- FDA Quality Management System Regulation questions for U.S. planning.
- Health Canada ISO 13485 and Medical Device Single Audit Program questions for Canada planning.
- European Union Medical Device Regulation quality-management-system questions where European planning is in scope.
What the readiness map cannot decide
The map cannot certify a company, predict an audit result, prove regulatory compliance, or decide market authorization. It makes the evidence and gaps visible before qualified review.
That boundary matters because founders often receive a simple request for an ISO 13485 certificate when the real decision is broader: who owns each process, what evidence exists, and what must be remediated before the next commercial or regulatory step.
What TrueMedDevice can prepare
TrueMedDevice can prepare the quality-system readiness map with process evidence, owner gaps, jurisdiction prompts, source links, and review questions.
Source ledger
What it can tell you
Public overview context for ISO 13485 quality-management-system requirements for medical devices.
What it cannot decide
Whether a specific company is certification-ready or compliant.
What it can tell you
FDA's public context for the Quality Management System Regulation and its relationship to ISO 13485.
What it cannot decide
Whether a specific company's quality system satisfies FDA requirements.
What it can tell you
FDA's public frequently asked questions about the Quality Management System Regulation.
What it cannot decide
A company-specific compliance, inspection, or enforcement position.
What it can tell you
Health Canada's public context for ISO 13485 quality-system expectations.
What it cannot decide
Whether a specific certificate or quality-system package satisfies a Canada licence requirement.
What it can tell you
Public context for audit-program expectations used in Canada medical device planning.
What it cannot decide
Whether a specific audit outcome, scope, or certificate is sufficient.
Frequently asked questions
Does an ISO 13485 readiness map prove we are ready for certification?
No. It organizes process evidence and gaps so qualified quality-system reviewers can assess readiness.
Why include FDA and Health Canada context in an ISO 13485 guide?
Because founders often ask about ISO 13485 when they are really preparing for U.S., Canada, or European market-entry questions. The readiness map keeps those contexts separate.
What should a startup collect first?
Collect the trigger decision, process evidence, process owners, missing records, jurisdiction prompts, and questions for Quality Assurance, Regulatory Affairs, consultants, auditors, or certification bodies.
Need the ISO 13485 readiness map before the next review?
TrueMedDevice can organize process evidence, owner gaps, jurisdiction prompts, source links, and quality-system questions.
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