Pre-production brief
| Field | Definition |
|---|---|
| Reader | Founder preparing a first medical device regulatory consultant meeting. |
| Trigger | The company is about to spend paid consultant time and needs a focused intake packet. |
| Blocked decision | The team cannot tell which assumptions are evidence, which are guesses, and which need professional judgment. |
| Useful output | A consultant intake packet with source links, source limits, and prioritized questions. |
What belongs in the intake packet
- One meeting question and the business decision behind it.
- Intended use, device description, user, setting, accessories, and product version.
- Target jurisdiction or jurisdictions for the first decision.
- Candidate public-source clues from FDA, Health Canada, or European Union sources as relevant.
- Safety-history source checks when similar devices, suppliers, or product families are part of the question.
- Open questions sorted by owner: founder, Regulatory Affairs, Quality Assurance, consultant, counsel, clinical, and commercial.
What not to bring as the only artifact
Do not bring only a list of acronyms, a copied competitor page, or a folder of unlabelled screenshots. Those artifacts force the consultant to spend paid time reconstructing context.
A better packet separates what is known, what is a public-source clue, what is assumed, and what the consultant is being asked to decide.
What TrueMedDevice can prepare
TrueMedDevice can prepare the consultant intake packet with source links, candidate clues, safety-history checks, source limits, and a prioritized question list.
Source ledger
What it can tell you
Public FDA database entry points for U.S. product-code, clearance, recall, and adverse-event source research.
What it cannot decide
Which FDA pathway, predicate, or evidence plan applies to a specific device.
What it can tell you
FDA's public 510(k) pathway context for consultant questions.
What it cannot decide
Whether a specific device is eligible for 510(k) or substantially equivalent.
What it can tell you
Public active licence records that may support Canada similar-device and licence-holder research.
What it cannot decide
Whether a specific device requires a Canada licence or qualifies for one.
What it can tell you
Public European Union Medical Device Regulation transition and guidance entry points.
What it cannot decide
A product-specific European Union conformity, certificate, or market-access position.
What it can tell you
Public adverse-event report narratives that may inform safety-history questions.
What it cannot decide
Safety, effectiveness, causation, complaint reportability, recall scope, or compliance status.
Frequently asked questions
What should I send before a regulatory consultant meeting?
Send one intake packet with the meeting question, intended use, device description, target jurisdiction, public-source clues, safety-history checks, source limits, and open questions.
Should I ask the consultant for a pathway answer immediately?
Ask for review of the pathway question, but do not present public-source clues as the final answer. The consultant needs product facts and professional judgment.
Can one packet cover U.S., Canada, and Europe?
It can frame the discussion, but each jurisdiction needs separate source limits and separate qualified review.
Need the intake packet before the consultant meeting?
TrueMedDevice can organize the intended-use note, source ledger, candidate clues, safety-history checks, source limits, and question list.
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