eStandards
Automate Standard Management and Document Updates
The perfect digital process to track Standards, MDCG guidelines and regulatory requirements for your company.
40.000+ Medical Devices already managed in meddevo eTD
Standard Management
Centralize your data to avoid redundancy and speed up the implementation processes.
Get Infos about new standards to stay on top of the game. Start implementation projects with a few clicks.
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Documents affected by the standard implementation will update themself. Fully integrated in a digital Technical Documentation.
Upload your standards
Stop managing standards in Excel Spreadsheets and countless documents in your Technical Documentation. After uploading your standards you have a perfect environment to manage them.
This way, you can:
Centralized Change Management & Automation
Implement new standards and guidances flawless into your technical documentation. Write your Impact Assessments and approve your new regulatory requirements. After your digital approval all impacted documents are ready for automatic updates.
This way, you can:
Keep the overview
Automated impact assessments are showing you change affected Technical Documentations, Audit-Review preparations and country submissions.
This way, you can:
2 weeks -> 6 hours
up to 90%
100%
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Calculate your ROI
Estimate your current effort and get a calculation of the annual time investment of your current process versus an eTD process.
40.000+ bereits in meddevo eTD verwaltete Medizinprodukte
In good company
eStandards - Rethinking Regulatory Compliance
Automate and Streamline Your Regulatory Requirements Monitoring
In the world of medical devices and IVDs, staying abreast of regulatory requirements is crucial. eStandards, our innovative solution, is designed to monitor your applicable regulatory requirements and automate the implementation process, ensuring you're always up-to-date with standards, legislations, guidances and your documentation.
Automated Regulatory Requirements
eStandards automatically checks your applicable regulatory requirements and keeps them current in your Technical Documentation. You decide when to implement them. Whether it's a standard, a whole legislation, or MDCG guidance documents, eStandards has got you covered and knows where you mentioned it in your documentation.
Intelligent Implementation Process
Implementing new standards and guidances into your technical documentation has never been easier. With eStandards, you can write your Impact Assessments and approve your new regulatory requirement. After your digital approval, all impacted documents are ready for automatic updates.
Ready for Content-Based Requirement Management
eStandards is ready for content-based requirement management. It ensures that your documents, such as the list of applied standards, GSPRs, Design & Development Documents, and Clinical Evaluations, are automatically updated.
Experience the Future of Regulatory Compliance
Are you ready to rethink regulatory compliance? Experience the power of automation with eStandards. Discover how our software can revolutionize your regulatory requirements process.
Want to learn more about automation of regulatory processes and technical documentation? Join the Academy!
The fastest and easiest way to digitalize your
RA & QA
