At Scarlet, we understand that regulatory submissions can be complex. Our goal is to make the submission process as smooth as possible by providing manufacturers with a structured way to present their technical documentation for assessment. However, Scarlet is not your technical file.
What Scarlet does
Scarlet offers a submission tool to help manufacturers compile and submit their technical documentation. The tool allows manufacturers a place to collect the necessary information, but it is not the technical file itself.
What Scarlet does not do
Scarlet does not:
Draft, review (other than to assess), or modify any of the substantive data.
Act as a storage system for ongoing technical documentation management.
Design, construct, market, or maintain the devices or processes under assessment.
Our role is strictly to provide the infrastructure for submission—not to create or manage your technical documentation. The responsibility for preparing and maintaining a complete and compliant technical file rests entirely with the manufacturer.
Why this distinction matters
Regulatory compliance requires manufacturers to have a well-maintained technical file, independent of the submission process. Relying on Scarlet as the sole location for your documentation may lead to confusion, delays, or even non-compliance if essential records are not managed properly outside of the submission tool.
Key takeaway
Scarlet is simply a tool to facilitate submission, not a repository for your ongoing technical documentation. Our submission tool is here to assist with assessments—but the responsibility for maintaining a compliant technical file remains with you.