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Legal Intelligence

Legal Applicability and Exposure

Determines which laws may apply from the entity, activity, contract, jurisdiction and legal triggers, and the exposure each implies.

Demonstration: Pellam Diagnostics Ltd (fictional) · Medical devices. Fictional data and a scripted answer.

The situation

Organisation
Pellam Diagnostics Ltd (fictional)
Who is asking
Head of legal and compliance
Industry
Medical devices
What happened
The company is about to start selling a device in a second region and must know which legal obligations come with it.

The question asked

Which obligations apply to us in the new region, given what we do there?

What it reads, and who can see the result

  • Company profile answers formFacts about the business in the region, answered by the legal team.
  • Obligation library registerSynthetic obligations with their conditions.
Reads
The answers the legal team gives, and the obligation library.
Does not read
Customer or patient data.
Permission
Legal team access to the library.
Who sees it
Legal, regulatory affairs and the commercial lead for the region.

Try it

Answer the questions about the organisation. Each rule becomes applicable, not applicable, or undetermined until the questions it depends on are answered: nothing is assumed.

Questions about the organisation

Will the device be placed on the market in the region by us rather than a distributor?

Does the device contain software that influences a clinical decision?

Will we store patient-identifiable data in the region?

Do we have more than 50 employees in the region?

ObligationWhereStatusEvidence and owner
Manufacturer registration
Synthetic Device Act, s. 4
Region BUndeterminedNeeds: Will the device be placed on the market in the region by us rather than a distributorNone needed
Software as a device: clinical evaluation
Synthetic Device Act, s. 9
Region BUndeterminedNeeds: Does the device contain software that influences a clinical decisionNone needed
Patient data localisation
Synthetic Data Code, art. 12
Region BUndeterminedNeeds: Will we store patient-identifiable data in the regionNone needed
Local safety officer
Synthetic Device Act, s. 15
Region BUndeterminedNeeds: Will the device be placed on the market in the region by us rather than a distributor; Do we have more than 50 employees in the regionNone needed
Distributor due diligence
Synthetic Device Act, s. 6
Region BUndeterminedNeeds: Will the device be placed on the market in the region by us rather than a distributorNone needed
Applies
0
Does not apply
0
Undetermined
5
Answered
0 of 4

The answer

Simulated answer. Written for this fictional case, not produced by a live model. Only the figures in it are computed, from what you decided above.

0 obligations apply, 0 do not, and 5 cannot be decided yet.

Each obligation depends on specific facts about the business [S1]. Where a fact has not been given, the obligation is undetermined and the table says which question it needs; it is never assumed either way [S2].

For the obligations that apply, the register names the evidence to keep and the owner: 0 items of evidence across 0 owners. Answer the remaining questions to settle the rest.

Relies on: S1 · Obligation library, regional extractS2 · Company profile, answered

Review and approval

The head of legal and compliance decides. Approving records which obligations apply and who owns each. It does not file anything with a regulator and does not assert compliance.

Not ready to approve. 5 obligations are undetermined until the questions they depend on are answered. Answer them first; nothing is assumed.

In the product this is a different person with the right permission. Here you play that role to see the rule.

What it produces

registerDraft, not approved

Obligation register, Region B

  • 0 applicable obligations, 0 evidence items, 0 owners.
  • 0 ruled out, with the answer that excluded each.

Limits of this example

  • The library is synthetic and illustrative.
  • A rule can depend on facts the questions do not ask; a lawyer confirms the register.
  • This is a scripted demonstration on fictional data. No model was called and no real organisation, person or result is shown.