---
description: Discover the benefits and disadvantages of SMEDTEC OS.  Learn the software price, see the description, and read the most helpful reviews for UK business users. 
image: https://gdm-localsites-assets-gfprod.imgix.net/images/capterra/og_logo-e5a8c001ed0bd1bb922639230fcea71a.png?auto=format%2Cenhance%2Ccompress
title: SMEDTEC OS Pricing, Cost & Reviews - Capterra UK 2026
---

Breadcrumb: [Home](/) > [Compliance Software](/directory/30110/compliance/software) > [SMEDTEC OS](/software/1105012/SMEDTEC-OS)

# SMEDTEC OS

Canonical: https://www.capterra.co.uk/software/1105012/SMEDTEC-OS

> SMEDTEC OS is software for medical device teams to manage submissions, compliance, and documentation across global markets.
> 
> Verdict: Rated \*\*\*\* by 0 users. Top-rated for **Overall Quality**.

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## Overview

### Who Uses SMEDTEC OS?

Small and mid-sized medical device manufacturers,regulatory consultancies, EU Authorised Representatives, UK Responsible Persons, distributors

## About the vendor

- **Company**: SMEDTEC OS

## Commercial Context

- **Starting Price**: £299.00
- **Pricing model**: Flat Rate (Free version available) (Free Trial)
- **Target Audience**: Self Employed, 2–10, 11–50, 51–200, 201–500, 501–1,000, 1,001–5,000, 5,001–10,000, 10,000+
- **Deployment & Platforms**: Cloud, SaaS, Web-based
- **Supported Languages**: French
- **Available Countries**: Argentina, Australia, Brazil, Canada, Chile, Colombia, France, Germany, Peru, United Kingdom, United States, Uruguay

## Features

- Audit Management
- Compliance Tracking
- Monitoring
- Risk Management

## Support Options

- Email/Help Desk
- FAQs/Forum
- Knowledge Base
- Phone Support
- Chat

## Category

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

## Alternatives

1. [HSI Donesafe](https://www.capterra.co.uk/software/141558/donesafe) — 4.8/5 (96 reviews)
2. [SiteDocs](https://www.capterra.co.uk/software/143579/sitedocs) — 4.8/5 (255 reviews)
3. [SafetyCulture](https://www.capterra.co.uk/software/141080/iauditor) — 4.6/5 (355 reviews)
4. [Adept](https://www.capterra.co.uk/software/201904/adept) — 4.6/5 (10 reviews)
5. [Know Your Customer](https://www.capterra.co.uk/software/186035/know-your-customer) — 5.0/5 (2 reviews)

## Links

- [View on Capterra](https://www.capterra.co.uk/software/1105012/SMEDTEC-OS)

## This page is available in the following languages

| Locale | URL |
| en | <https://www.capterra.com/p/10049602/SMEDTEC-OS/> |
| en-AE | <https://www.capterra.ae/software/1105012/SMEDTEC-OS> |
| en-AU | <https://www.capterra.com.au/software/1105012/SMEDTEC-OS> |
| en-CA | <https://www.capterra.ca/software/1105012/SMEDTEC-OS> |
| en-GB | <https://www.capterra.co.uk/software/1105012/SMEDTEC-OS> |
| en-IE | <https://www.capterra.ie/software/1105012/SMEDTEC-OS> |
| en-IL | <https://www.capterra.co.il/software/1105012/SMEDTEC-OS> |
| en-IN | <https://www.capterra.in/software/1105012/SMEDTEC-OS> |
| en-NZ | <https://www.capterra.co.nz/software/1105012/SMEDTEC-OS> |
| en-SG | <https://www.capterra.com.sg/software/1105012/SMEDTEC-OS> |
| en-ZA | <https://www.capterra.co.za/software/1105012/SMEDTEC-OS> |

-----

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