# SMEDTEC OS Software Pricing, Alternatives & More 2026 | Capterra > With the help of Capterra, learn about SMEDTEC OS Software - reviews, pricing plans, popular comparisons to other Compliance products and more. Source: https://www.capterra.com/p/10049602/SMEDTEC-OS --- # SMEDTEC OS Software Review 2026: Features, Reviews, Integrations, Pros & Cons Last updated on July 6, 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) SMEDTEC OS ## What is SMEDTEC OS? SMEDTEC OS is a regulatory operations platform centralizing workflows for medical device submissions, compliance tracking, and technical documentation across global markets. It unifies regulatory data, enabling teams to manage the product lifecycle from a single workspace. Supporting frameworks like EU MDR, FDA pathways, UKCA, and country-specific registrations, the platform allows teams to define products, link classification codes, and manage submission dossiers. Features include submission tracking with assignees and due dates, structured metadata for FDA real-world evidence, and a version-controlled document vault. Dashboards monitor license numbers, renewal dates, and holder details across markets like MHRA, TGA, Health Canada, and EUDAMED. Lifecycle tools handle post-market surveillance, design dossier maintenance, and audit tracking. With an immutable audit trail, SOC 2 Type II certification, and GDPR compliance, SMEDTEC OS aligns with EU MDR workflow requirements. ## What is SMEDTEC OS used for? [Compliance](https://www.capterra.com/compliance-software/) Overall rating Based on 0 user reviews Reviews sentiment Positive \- Neutral \- Negative \- Starting price £299 Flat Rate, Per Month Free trial available Includes Free Version 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 SMEDTEC OS?[Manage this product listing](https://digitalmarkets.gartner.com/get-listed/claim-bx?url=https://os.smedtec.co.uk/&name=SMEDTEC OS) ## Features Features with the highest number of reviews are displayed first. Those that have no reviews appear next, sorted alphabetically. Activity Dashboard Dashboard to view the status of ongoing processes, identify current incidents and track past activities Activity Tracking Track and document all activities across devices, networks, and other systems Audit Management Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws Audit Trail A record of all activities within the system, including user access, changes made, etc. Compliance Tracking Track and report regulatory data to either internal management or external stakeholders FDA Compliance Track and ensure quality of products in accordance with food and drug administration (FDA) act SMEDTEC OS 10 features Dashboard to view the status of ongoing processes, identify current incidents and track past activities Track and document all activities across devices, networks, and other systems Plan, schedule, and execute organization's accounts and assets to ensure compliance with policies and laws A record of all activities within the system, including user access, changes made, etc. Track and report regulatory data to either internal management or external stakeholders Track and ensure quality of products in accordance with food and drug administration (FDA) act Observe and track the demand, usage, progress or quality of a system, product, or user Real-time updates, analysis, and insights on regulatory changes and developments affecting specific industries or jurisdictions 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 Trial Free Version Starter £299.00 Flat Rate,Per Month Growth £549.00 Flat Rate,Per Month Scale £1,499 Flat Rate,Per Month Enterprise £0.00 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.