---
description: Learn more about Omakyn price, benefits, and disadvantages for businesses in South Africa. Read reviews from verified users and discover similar tools.
image: https://gdm-localsites-assets-gfprod.imgix.net/images/capterra/og_logo-e5a8c001ed0bd1bb922639230fcea71a.png?auto=format%2Cenhance%2Ccompress
title: Omakyn Price, Reviews & Features - Capterra South Africa 2026
---

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

# Omakyn

Canonical: https://www.capterra.co.za/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 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**: US$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

## Support Options

- Email/Help Desk

## Category

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

## Alternatives

1. [eTHIC](https://www.capterra.co.za/software/181123/ethic) — 4.7/5 (6 reviews)
2. [ManageEngine ADAudit Plus](https://www.capterra.co.za/software/210774/adaudit-plus) — 4.5/5 (101 reviews)
3. [ManageEngine Network Configuration Manager](https://www.capterra.co.za/software/172274/network-configuration-manager) — 4.5/5 (293 reviews)
4. [Digital Integrated Management System](https://www.capterra.co.za/software/68590/enterprise-process-center-epc) — 4.8/5 (23 reviews)
5. [ManageEngine EventLog Analyzer](https://www.capterra.co.za/software/175558/eventlog-analyzer) — 4.8/5 (5 reviews)

## Links

- [View on Capterra](https://www.capterra.co.za/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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