Book a Scoping Call FDA Medical Device Documentation
FDA medical device regulatory writing for 510(k), De Novo, and PMA submissions, including eSTAR content, clinical evidence narratives, and FDA response support.
Specialist document services
Medical device 510(k) writing support for eSTAR content, substantial equivalence narratives, device descriptions, clinical evidence, and submission review.
Explore service 02De Novo Writing Services for Medical DevicesFDA De Novo writing support for novel medical devices, including benefit risk narratives, classification rationale, special controls, and clinical evidence.
Explore service 03PMA Writing Services for Medical DevicesPremarket Approval writing support for high risk medical devices, including clinical modules, study reports, benefit risk narratives, and evidence integration.
Explore serviceFree FDA regulatory resource
Explore the IMTS FDA Reg-AdvisorExplore the educational advisor interface for FDA pathways, predicates, and clinical evidence. Question answering is coming soon.
The IMTS perspective
Indus MedTech Solutions provides medical-device-focused regulatory and clinical writing for FDA programs. We help teams turn device information, testing, clinical data, literature, and regulatory strategy into clear submission content for 510(k), De Novo, and PMA pathways.
FDA submissions and clinical programs require clear documentation that connects the device, indications, testing, clinical evidence, and regulatory rationale. IMTS supports medical device teams with focused writing and evidence development across premarket and clinical deliverables.
A strong document anticipates the reviewer's question, makes the basis for each conclusion easy to follow, and keeps terminology and claims consistent across submission modules, study documents, labeling, and supporting evidence.
Direct answers
IMTS supports writing for 510(k), De Novo, and PMA submissions, including eSTAR content, device and clinical evidence narratives, clinical protocols, Investigator's Brochures, Clinical Study Reports, literature reviews, benefit-risk discussions, and responses to FDA questions.
We help connect the proposed device, indications for use, predicate comparison, technological characteristics, performance testing, clinical evidence, and labeling into a consistent substantial-equivalence narrative.
Medical device companies engage IMTS when they need specialized writing capacity for a new submission, a complex clinical evidence package, cross-functional document coordination, remediation of inconsistent content, or focused responses during FDA review.
IMTS is focused exclusively on medical devices. Our advanced-degree writers understand how regulatory strategy, clinical evidence, testing, claims, risk, labeling, and scientific communication must remain aligned across an FDA program.
Scope of support
How we work
Define the intended use, claims, pathway, evidence needs, source documents, and key review questions.
Organize technical and clinical evidence into concise sections with consistent terminology and clear rationale.
Resolve comments, maintain source traceability, and prepare documentation for efficient internal and FDA review.
Start a conversation
We will help define the scope, source materials, review process, and practical next step.
Book a Scoping Call