meddevo eStandards
Automate Standard Management and Document Updates
The perfect digital process to track Standards, MDCG guidelines and regulatory requirements for your company. Join the eTD user community with more than 130.000 medical devices.
Single Source of Truth
Centralize your data to avoid redundancy and speed up implementation processes.
Update Notifications
Get infos about new standards to stay on top of the game. Start implementation projects with a few clicks.
Automated Document Updates
Documents affected by standard implementation will update themselves. Fully integrated in a digital Technical Documentation.
Three steps to automated standard management
A streamlined process to keep your regulatory requirements up to date
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:
- Monitoring Standards, MDCG and Legislation in one place
- Collaborate with your team in one place
- Automate documents like: List of applied standards, GSPR Declaration of Conformity and many more
Centralized Change Management & Automation
Implement new standards and guidances flawlessly 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:
- Implement changes in a quick and documented process
- Get automated redlining of impacted Documents
- Update affected Documents automatically
Keep the overview
Automated impact assessments are showing you change affected Technical Documentations, Audit-Review preparations and country submissions.
This way, you can:
- Immediately identify regulatory impacts
- Update TDs and Submissions automatically
- Enjoying a process on autopilot
Standards
Pending
Submissions
eStandards - Rethinking Regulatory Compliance
In the world of medical devices and IVDs, staying abreast of regulatory requirements is crucial. eStandards is designed to monitor your applicable regulatory requirements and automate the implementation process.
Standards Monitoring
Track standards, legislations, and MDCG guidance documents in one centralized location.
Impact Analysis
Know exactly where each standard is referenced in your documentation before implementing changes.
Digital Approval
Implement new standards with documented approval workflows and audit trails.
Auto-Updates
All impacted documents are ready for automatic updates after approval.
Document Integration
Automatically update lists of applied standards, GSPR, Declaration of Conformity and more.
Team Collaboration
Collaborate with your team in one place with clear responsibilities and status tracking.
Automate and Streamline Your Regulatory Requirements Monitoring
eStandards automatically checks your applicable regulatory requirements and keeps them current in your Technical Documentation. You decide when to implement them.
- Automatically checks your applicable regulatory requirements
- Keeps standards current in your Technical Documentation
- Covers standards, legislations, and MDCG guidance documents
- Knows where requirements are mentioned in your documentation
ISO 13485:2016
MDR 2017/745
MDCG 2019-9
ISO 14971:2019
Write Impact Assessment
Digital Approval
Automatic Document Updates
Implementing new standards 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 ensures that your documents are automatically updated when requirements change. Your documentation stays in sync with your compliance status.
Documents like the list of applied standards, GSPRs, Design & Development Documents, and Clinical Evaluations are automatically updated.
100% Integration – meddevo fits perfectly into your existing tool and document landscape by integrating software like ALM, PLM, ERP via REST API or managing your existing documents and data.
Real impact for regulatory teams
2 weeks → 6 hours
Reduced workload for one standard update in a client case
up to 90%
Process acceleration
100%
Integration in your Digital Technical Documentation
"Thanks to meddevo, we have been able to manage our technical documentation efficiently. I can recommend meddevo to anyone working in the medical device industry who is looking for a reliable and up-to-date eTD platform."
See the value for your organization
Estimate your current effort and get a calculation of the annual time investment of your current process versus an eTD process.
Experience the Future of Regulatory Compliance
Are you ready to rethink regulatory compliance? Experience the power of automation with eStandards.
Schedule a demo to see eStandards in action
Evaluate with your own standards and documents
Get onboarded with dedicated support
Go live and automate your compliance
Ready to automate your standard management?
eStandards revolutionizes how you manage regulatory requirements.
Stop chasing updates. Start automating compliance.
No credit card required. Start your evaluation today.