Be clear about the work. Be honest about the limits.
You should know what an engagement includes, who is responsible for each input, and what remains unresolved. Our proposed working standard makes those expectations explicit before the work begins.
Commitments made before work begins
Defined scope
Deliverables, dependencies, fees and timing agreed in writing.
Traceable work
Sources and material assumptions identified in the documentation.
Direct communication
A named contact and an agreed path for questions.
No outcome guarantees.
FDA determines inspection findings and admissibility under the laws it administers. Clearance does not guarantee a particular inspection outcome, FDA approval or shipment release. Services are limited to the agreed written scope.
Scope boundaries
Clearance provides consulting and documentation support. It is not an attestation or assurance engagement, and nothing on this site is legal advice.
Work outside the agreed scope is explained before it is accepted, and where appropriate we can discuss whether another specialist should be involved.
How unresolved questions are handled
Open questions are listed in the documentation with what is known, what is assumed and what is needed to close them. They are not settled by assumption.
Start with the scope.
Tell us what you need. Before any work begins, the deliverables, required inputs, responsibilities and timing are agreed in writing.