# Omakyn Software Pricing, Alternatives & More 2026 | Capterra > With the help of Capterra, learn about Omakyn Software - reviews, pricing plans, popular comparisons to other Compliance products and more. Source: https://www.capterra.com/p/10047450/Omakyn --- # Omakyn Software Review 2026: Features, Reviews, Integrations, Pros & Cons Last updated on June 25, 2026 Provider data verified by our Software Research team, and reviews moderated by our Reviews Verification team. [Description](#description)[Use cases](#use-cases)[Features](#features)[Pricing](#pricing)[Support](#support) Omakyn ## What is Omakyn? Omakyn is compliance software that automates FDA cybersecurity gap analysis for medical device manufacturers. It analyzes devices across the nine compliance areas of the FDA's Section 524B premarket cybersecurity guidance, delivering a gap report in minutes. Traditional audits take months and often reveal gaps only during FDA review. With Omakyn, users answer eighteen questions about device connectivity and security; the engine maps responses to FDA compliance dimensions and identifies gaps by severity. The software generates a gap report with a compliance score, risk assessment, and prioritized remediation roadmap. The analysis covers cyber device classification, secure development practices, and threat modeling, with each gap linked to the relevant FDA guidance section. The platform maps to FDA Section 524B and the NIST Cybersecurity Framework. Reports can be shared with teams, consultants, and stakeholders. Built for small and early-stage manufacturers and the regulatory consultants ## What is Omakyn used for? [Compliance](https://www.capterra.com/compliance-software/) Overall rating Based on 0 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price $1497 Flat Rate, One Time Free trial not available Capterra Shortlist charts the highest-rated and most popular products... Our "Best of" badge program showcases products with the highest ratings... Our "Best of" badge program showcases products with the highest ratings... Do you work for Omakyn?[Manage this product listing](https://digitalmarkets.gartner.com/get-listed/claim-bx?url=https://omakyn.com/&name=Omakyn) ## Features Features with the highest number of reviews are displayed first. Those that have no reviews appear next, sorted alphabetically. Assessment Management Creation, administration, and evaluation of assessments or tests Audit Management Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws Compliance Tracking Track and report regulatory data to either internal management or external stakeholders Data Security Protect sensitive data for digital privacy Data Visualization Graphical representation of data FDA Compliance Track and ensure quality of products in accordance with food and drug administration (FDA) act Omakyn 8 features Creation, administration, and evaluation of assessments or tests Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws Track and report regulatory data to either internal management or external stakeholders Protect sensitive data for digital privacy Graphical representation of data Track and ensure quality of products in accordance with food and drug administration (FDA) act Preparing and submitting reports to regulatory authorities in compliance with industry-specific rules, regulations, and standards Process of identifying, evaluating, mitigating, addressing and reporting on potential risks or uncertainties Get Advice We can help you find the software with the features you need. ## Pricing Free Version Gap Analyzer $0.00 It includes: - 18-question assessment - Compliance score & risk level - Identification of the top 3 critical gaps - Instant AI-powered gap report generated in under 5 minutes - No credit card required - No sales call required Starter Plan $1,497 Flat Rate,One Time It includes: - Full gap analysis report (identifies all gaps) - Prioritized remediation roadmap - FDA section references for each gap - Shareable report summary for team collaboration - Personalized email analysis of the top 3 gaps - Personalized action checklist Assessment Plan $4,997 Flat Rate,One Time It includes: - Includes all features of the Starter Plan - Review of existing documentation - SBOM (Software Bill of Materials) gap analysis (if available) - Written recommendations for each area of compliance - Detailed written analysis for each area - 30-day email follow-up support for further assistance Connect with a Capterra advisor for a free 15-minute consultation Get a personalized software list aligned to your business needs with guidance from our expert advisors. Our team has helped 1 million+ businesses like yours find options that fit their needs. ## Support, customer service and training options Support - Email/Help Desk - FAQs/Forum - Knowledge Base - Phone Support - 24/7 (Live rep) - Chat Training - In Person - Live Online - Webinars - Documentation - Videos Deployment - Web - Android - iPhone/iPad Typical users - Freelancers - Small businesses - Mid size businesses - Enterprises ## Top-rated software of 2026 ### Fill out the form and we'll send a list of the top-rated software based on real user reviews directly to your inbox.