Solutions · medtech
MedTech Blueprints
Produce review-ready MedTech regulatory documentation faster, with built-in traceability.
510(k) submissions & updates
Clinical Evaluation Reports (CERs)
Clinical Evaluation Plans (CEPs)
State of the Art (SOTA) reviews
Predicate device comparisons
Regulatory responses & supplements
MedTech Blueprints encode regulatory expectations into structured, repeatable workflows — enabling teams to produce documentation that’s clear, defensible, and built to withstand review.
“Finalizing a CER used to take weeks of back-and-forth across regulatory, clinical, and quality teams. With Everest, we had a near-final draft in under an hour.”
CER Blueprint™
MDR-aligned clinical evaluation — structured the way notified bodies expect
The CER Blueprint™ encodes EU MDR Annex XIV requirements and supporting MDCG and MEDDEV guidance into a structured, defensible clinical evaluation workflow.
Regulator-aligned CER structure
Applies a consistent framework across clinical background, evaluation, and conclusions.
Defensible clinical literature analysis
Structures literature review outputs into analytical, review-ready evaluations — not just summaries.
Explicit claim-to-evidence linkage
Maintains clear alignment between device claims, clinical data, and conclusions.
Lifecycle-ready updates
Enables efficient updates as programs expand, studies are added, or CMC information changes—without starting from scratch.
“Everest cut our 510(k) preparation time dramatically while improving structure and reviewer readiness.”
Regulatory Affairs Consultant
MedTech Company
510(k) Blueprint™
FDA-aligned submission preparation — built around reviewer logic
The 510(k) Blueprint™ structures submission content according to FDA expectations, helping teams assemble clear, consistent, and defensible submissions.
FDA-aligned submission structure
Organizes content around the FDA’s 510(k) review flow, aligning sections, comparisons, and justifications to how reviewers assess substantial equivalence.
Predicate device comparisons
Structures and maintains consistency across device descriptions, predicate comparisons, and performance claims.
Claim-to-data alignment
Ensures bench, performance, and testing data clearly and consistently support stated claims.
Early gap identification
Surfaces missing data or weak rationales before submission—reducing late-stage rework and FDA questions.
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