Full TechDoc Automation Platform for Medical Devices and In Vitro Diagnostica
Post Market Surveillance
UDI & EUDAMED
MDR / IVDR GSPRs
Content based Technical Documentation
Full configurable multi language Content Management allows you focusing on Data, not Documents. Out of the box EU-MDR, IVDR ready and MDSAP countries enabled regulatory frameworks. Automate your Technical Documentation. Set it on autopilot with the meddevo eTD Platform.
Single Source of Truth, Audit Trail, 21 CFR Part 11 Compliant
Data Overview with Export / Import
MDR / IVDR ready according ANNEX I, II, III
Worldwide management e.g.: MDR, IVDR, PPE, ANVISA, FDA
Integrated Document Writer let you write rich and intelligent documents that will keep themself up to date. Reusing redundant free data out of your eTD pushing your data integrity to new hights. Start from scratch, use templates or create your own. Set your documents on autopilot.
Never manage Dossiers by copy & paste or drag & drop again. Virtual Folders fills automatically with your Documents in your desired format and product scope. Keep track of Submissions and Audits anytime.
Pre-Configured for EU-MDR, FDA, etc.
Configuration of your own structures
Automated Updates of Submissions
No document redundancies
Let the Inspectors work for you!
Data can be validated, Documents checked for up to dateness and Folder Structures or Submissions monitored for correct data.
Folder & Submission Tracking
Manage QM-Processes synced to your eTD!
Technical Documentation connected to your QM Processes gives you deep data insight and tracking capabilities.
Setup Custom Processes
Real Regulatory eTD Functions
Every feature, every function, every button - Designed for your regulatory process
Shift the focus from documents to high-quality, redundancy-free content. Set a new standard for data integrity and a single source of truth.
Automate your documents with templates to put them on autopilot. Includes automatic redlining for future versions and one-click updates.
Integrated Document Writer
Write intelligent documents connected to your single source of truth. Finally, a document that works for you and lets you know when it is out of date.
Inspect your TechFile content for GAPs and keep track of your projects. e.g: If the product is sterile, the inspector will tell you what is missing.
Your documents are constantly monitored. As soon as new data becomes available, your documents will turn "red" so you are aware of any updates that need to be made.
Folder & Submission Inspector
Every single TechFile version is monitored and will tell you if outdated documents have been used in the past for registration or audits. Updating your TechFile is now a snap!
Automated Folder Structures
Never create technical documentation by duplicating folders and documents again. Virtual Folders takes over and presents your TD the way you need it.
Data Connection Monitoring
Every bit of data is connected. Have deep data insights in your eTD. Where is this particular indication used in the portfolio? You know in seconds.
Write down your thoughts where they belong. To a specific content in your eTD. Your colleagues can help you! Communication within your eTD is fun.
No matter if you have 1 product or thousands. Changes are fast and covered by the audit trail.
Dynamic Approval Workflows
Set up dynamic approval workflows for your digital records or documents. Eliminate printing and scanning. In compliance with 21 CFR Part 11
Full Audit Trail
Your data is covered by a full audit trail / version history. In compliance with 21 CFR Part 11
More Collections & Processes
EUDAMED / UDI Data
EUDAMED data is eTD data. No need to maintain this type of data in a redundant database. Keep it lean.
Implement standards and guidelines in a best-practice process. Automatically incorporate new data into your technical documentation.
Your ANNEX I will be always up to date. A single source of truth is covering your important evidence document.
Track your contacts & legal entities to use data in your technical documentation. All data and documents in one place.
Components & Materials
Your component data appears in multiple areas of your TechFile. Automate this data to keep your records clean.
Customize your eTD
meddevo eTD is an open platform. You are free to build the structures and processes you need to meet the needs of your company.
No credit card required
The fastest and easiest way to digitalize your RA & QA