---
description: Get detailed information about Omakyn usability, features, price, benefits and disadvantages from verified user experiences. Read reviews and discover similar tools on Capterra United Arab Emirates.
image: https://gdm-localsites-assets-gfprod.imgix.net/images/capterra/og_logo-e5a8c001ed0bd1bb922639230fcea71a.png?auto=format%2Cenhance%2Ccompress
title: Omakyn Price, Reviews & Ratings - Capterra United Arab Emirates 2026
---

Breadcrumb: [Home](/) > [Compliance Software](/directory/30110/compliance/software) > [Omakyn](/software/1102798/Omakyn)

# Omakyn

Canonical: https://www.capterra.ae/software/1102798/Omakyn

> Omakyn is compliance software automating FDA cybersecurity gap analysis for medical device manufacturers across nine required areas.
> 
> Verdict: Rated \*\*\*\* by 0 users. Top-rated for **Overall Quality**.

-----

## Overview

### Who Uses Omakyn?

Small and early-stage medical device manufacturers preparing FDA submissions, and the regulatory/RA-QA consultants who serve them. Typical roles: regulatory affairs and quality (RA/QA) leads, device-s

## About the vendor

- **Company**: Omakyn

## Commercial Context

- **Starting Price**: $0.00
- **Pricing model**: Flat Rate (Free version available)
- **Target Audience**: Self Employed, 2–10, 11–50, 51–200
- **Deployment & Platforms**: Cloud, SaaS, Web-based
- **Supported Languages**: English, Spanish
- **Available Countries**: United States

## Features

- Audit Management
- Compliance Tracking
- Risk Management Software

## Support Options

- Email/Help Desk

## Category

- [Compliance Software](https://www.capterra.ae/directory/30110/compliance/software)

## Alternatives

1. [Xero](https://www.capterra.ae/software/169561/xero) — 4.4/5 (3311 reviews)
2. [eTHIC](https://www.capterra.ae/software/181123/ethic) — 4.7/5 (6 reviews)
3. [Flagright](https://www.capterra.ae/software/1067041/flagright) — 4.9/5 (14 reviews)
4. [Netwrix Change Tracker](https://www.capterra.ae/software/118082/nnt-change-tracker-enterprise) — 3.0/5 (1 reviews)
5. [ManageEngine ADAudit Plus](https://www.capterra.ae/software/210774/adaudit-plus) — 4.5/5 (101 reviews)

## Links

- [View on Capterra](https://www.capterra.ae/software/1102798/Omakyn)

## This page is available in the following languages

| Locale | URL |
| en | <https://www.capterra.com/p/10047450/Omakyn/> |
| en-AE | <https://www.capterra.ae/software/1102798/Omakyn> |
| en-AU | <https://www.capterra.com.au/software/1102798/Omakyn> |
| en-CA | <https://www.capterra.ca/software/1102798/Omakyn> |
| en-GB | <https://www.capterra.co.uk/software/1102798/Omakyn> |
| en-IE | <https://www.capterra.ie/software/1102798/Omakyn> |
| en-IL | <https://www.capterra.co.il/software/1102798/Omakyn> |
| en-IN | <https://www.capterra.in/software/1102798/Omakyn> |
| en-NZ | <https://www.capterra.co.nz/software/1102798/Omakyn> |
| en-SG | <https://www.capterra.com.sg/software/1102798/Omakyn> |
| en-ZA | <https://www.capterra.co.za/software/1102798/Omakyn> |

-----

## Structured Data

<script type="application/ld+json">
  {"@context":"https://schema.org","@graph":[{"name":null,"address":{"@type":"PostalAddress","addressLocality":null,"addressRegion":null,"postalCode":null,"streetAddress":null},"description":"Capterra UAE helps millions of people find the best business software. With software reviews, ratings, infographics, and the most comprehensive list of business software.","email":"info@capterra.ae","url":"https://www.capterra.ae/","logo":"https://dm-localsites-assets-prod.imgix.net/images/capterra/logo-a9b3b18653bd44e574e5108c22ab4d3c.svg","@id":"https://www.capterra.ae/#organization","@type":"Organization","parentOrganization":"G2.com, Inc.","sameAs":["https://twitter.com/capterra","https://www.facebook.com/Capterra/","https://www.linkedin.com/company/capterra","https://www.instagram.com/capterra/","https://www.youtube.com/user/CapterraTV"]},{"name":"Omakyn","description":"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","image":"https://gdm-catalog-fmapi-prod.imgix.net/ProductScreenshot/9bc128e4-e927-4ec6-875b-8f64779c765e.png","url":"https://www.capterra.ae/software/1102798/Omakyn","@id":"https://www.capterra.ae/software/1102798/Omakyn#software","@type":"SoftwareApplication","applicationCategory":"BusinessApplication","publisher":{"@id":"https://www.capterra.ae/#organization"},"offers":{"price":"0","@type":"Offer","priceCurrency":"USD"},"operatingSystem":"Cloud"},{"@id":"https://www.capterra.ae/software/1102798/Omakyn#faqs","@type":"FAQPage","mainEntity":[{"name":"What Is Omakyn?","@type":"Question","acceptedAnswer":{"text":"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","@type":"Answer"}},{"name":"Who Uses Omakyn?","@type":"Question","acceptedAnswer":{"text":"Small and early-stage medical device manufacturers preparing FDA submissions, and the regulatory/RA-QA consultants who serve them. Typical roles: regulatory affairs and quality (RA/QA) leads, device-s","@type":"Answer"}}]},{"@id":"https://www.capterra.ae/software/1102798/Omakyn#breadcrumblist","@type":"BreadcrumbList","itemListElement":[{"name":"Home","position":1,"item":"/","@type":"ListItem"},{"name":"Compliance Software","position":2,"item":"/directory/30110/compliance/software","@type":"ListItem"},{"name":"Omakyn","position":3,"item":"/software/1102798/Omakyn","@type":"ListItem"}]}]}
</script>