Define the equivalence story
Align the proposed device, predicate, indications, technological characteristics, and evidence expectations.
Book a Scoping Call FDA 510(k) Submissions
510(k) Writing Services for Medical Devices
Medical device 510(k) writing support for eSTAR content, substantial equivalence narratives, device descriptions, clinical evidence, and submission review.
The IMTS perspective
Evidence that stands up to scrutiny.
A 510(k) submission must give FDA a clear basis for determining substantial equivalence. IMTS helps medical device teams develop consistent, reviewer focused content across eSTAR sections, supporting evidence, testing summaries, device descriptions, and labeling.
The submission needs to explain not only what was tested, but why the chosen predicate, technological comparison, performance data, and clinical evidence support the proposed indications and substantial equivalence conclusion.
Scope of support
What we can deliver.
- 01eSTAR content development
- 02Predicate and substantial equivalence narratives
- 03Device description and indications content
- 04Performance and clinical evidence summaries
- 05Additional information response support
How we work
A focused path from source evidence to final document.
Develop connected content
Write concise submission sections that connect testing and evidence to each identified comparison or question.
Prepare for FDA review
Cross check consistency, resolve internal comments, and support focused responses to additional information requests.
Start a conversation
Bring us the document that needs to move forward.
We will help define the scope, source materials, review process, and practical next step.
Book a Scoping Call