---
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**.

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## Overview

### Who Uses Omakyn?

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

## About the vendor

- **Company**: Omakyn

## Commercial Context

- **Starting Price**: $0.00
- **Pricing model**: Flat Rate (Free version available)
- **Pricing Details**: Fixed, published prices. Free Gap Analyzer to start, no sales call.

What we do not do: penetration and vulnerability testing (FDA requires the testing evidence, so you will need a testing provider), SBOM generation, source code review, implementing the remediation, full regulatory strategy, and final sign-off. If you have an SBOM, we review it against what FDA expects.

Also selling into the EU? The Cyber Resilience Act already has wearables in scope, with vulnerability reporting obligations starting 11 September 2026.
- **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

- 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 (3323 reviews)
2. [Netwrix Change Tracker](https://www.capterra.ae/software/118082/nnt-change-tracker-enterprise) — 3.0/5 (1 reviews)
3. [Flagright](https://www.capterra.ae/software/1067041/flagright) — 4.9/5 (16 reviews)
4. [ManageEngine ADAudit Plus](https://www.capterra.ae/software/210774/adaudit-plus) — 4.5/5 (103 reviews)
5. [eTHIC](https://www.capterra.ae/software/181123/ethic) — 4.7/5 (6 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> |

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