OpenRegulatory

Document Management & eSignature Tools

Get Verified & Update Profile Claimed profiles go to the top of search results. Get verified now, it takes just a couple minutes. Visit Report

An AI-powered, all-in-one eQMS for medical devices that consolidates regulatory documentation, quality processes, and cross-functional collaboration into a single platform, replacing scattered tools, PDFs, and manual spreadsheets with workflow-driven governance and solid audit trails.

Core features include real-time completeness checks, multi-format exports (DOCX, PDF, Markdown, HTML), audit-ready e-signatures compliant with 21 CFR Part 11, out-of-the-box ISO 13485 and EU MDR readiness, and pre-built templates mapped to ISO 13485, IEC 62304, ISO 14971, and IEC 62366, plus a free learning community for regulation education and peer support, designed for lean product teams, regulatory professionals, and quality managers to accelerate compliance and speed time-to-market.

OpenRegulatory can be found in Document Management & eSignature Tools categories.

The most similar products to OpenRegulatory are:

eSignBase Verified profile Promoted → Aligned Elements → Threeqa Verified profile → Kivo →

Screenshots

YouTube Videos

Details

OpenRegulatory Main Features

• Q&A Section
  Our Questions & Answers section helps you find answers to common medical device compliance questions.
• eQMS Software
  Our eQMS software helps teams automate their medical device documentation processes.
• Free Templates
  We provide free templates to help you create your own medical device documents.
• Easy Compliance
  We help you understand and follow medical device rules easily and clearly.
• Automation Features
  Our software allows you to automate tasks, keeping you compliant and ahead of competitors.
• Consulting Services
  We offer consulting to help you finish your medical device projects faster.
• Step-by-Step Wizard
  Our Wizard video course guides you through making your own documents, even if you have no experience.
• AI-Enabled Templates
  We include free AI-enabled templates to help you get started easily.
• Support for Startups
  We have worked with over 150 companies and are ready to support you with your compliance needs.
• Free Learning Resources
  You can read free articles to learn about medical device compliance in simple language.
• Fast Documentation Creation
  You can quickly create your medical device documents and prepare for audits.

OpenRegulatory Benefits

• Automates Processes
  The software helps you automate tasks, saving you time and making your work faster.
• Simplifies Compliance
  It makes understanding medical device rules easy, so you can focus on building your product.
• Provides Free Resources
  You can access free articles and templates to help you create the right documents without extra cost.
• Offers Community Support
  You can connect with others in the Slack Community to share questions and get help.
• Guides Documentation Creation
  The step-by-step Wizard helps you create your documents quickly, even if you have no prior knowledge.
• Supports Continuous Compliance
  With automation, you can ensure you always meet the rules, keeping you ahead of competitors.

Who should use OpenRegulatory?

• Startups
  Startups can use our software to easily follow medical device rules, so they can focus on building their products.
• Developers
  Developers can create their own documentation fast, helping them pass audits without delays.
• Consultants
  Consultants can use our resources to help their clients quickly understand and meet medical device regulations.
• Regulatory Professionals
  Regulatory professionals can find clear articles and answers to their questions, making their job easier.
• Medical Device Manufacturers
  Manufacturers can benefit from our templates and automation tools to save time and ensure they meet compliance.

Verified Badge

<a href="https://saasbrowser.com/en/saas/251428/openregulatory" target="_blank" rel="noopener"><img src="https://files.saasbrowser.com/03vv2obr4ei1l9cjkn69r2fcz4f0" alt="OpenRegulatory - SaaS Browser Verified Badge" width="200" height="133" /></a>

Copy Badge

<a href="https://saasbrowser.com/en/saas/251428/openregulatory" target="_blank" rel="noopener"><img src="https://files.saasbrowser.com/07kgcowwr5n7r4bg1ovmn58dehg3" alt="OpenRegulatory - SaaS Browser Verified Badge" width="200" height="133" /></a>

Copy Badge

OpenRegulatory Alternatives

eSignBase

Verified profile

Promoted

This electronic signature platform enables users to securely create, manage, ...

Aligned Elements

A comprehensive, integrated platform delivers end-to-end quality management a...

Threeqa

Verified profile

The platform is a comprehensive quality management system and application lif...

Kivo

This comprehensive document and process management platform is designed speci...

Technologies Used

View All Technologies

Affiliate Program