eSolution

meddevo eTD

Full TechDoc Automation Platform for Medical Devices
and In Vitro Diagnostica



Applied
Standards



Post Market
Surveillance



Clinical Evaluation



UDI & EUDAMED



Risk
Management



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

Comment functions and Bulk Changes

Key Features of eTD Platform

Intelligent Documents and Automation

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.

Integrated Document Writer

Intelligent eTD Data connection

Automated Updates

Document Templates

Key Features of eTD Platform

Automated Folder Structures and Submissions

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.

Data Validation

Document Monitoring

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.

Change Documentation

CAPA Documentation

Complaint Documentation

Setup Custom Processes

Real Regulatory eTD Functions

Every feature, every function, every button - Designed for your regulatory process

Content Management

Shift the focus from documents to high-quality, redundancy-free content. Set a new standard for data integrity and a single source of truth.

Document Generation

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.

Content Inspector

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.

Document Inspector

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.

Collaboration

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.

Bulk Changes

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.

Standard Management

Implement standards and guidelines in a best-practice process. Automatically incorporate new data into your technical documentation.

GSPR Manager

Your ANNEX I will be always up to date. A single source of truth is covering your important evidence document.

Supplier Database

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.

Discovery Call & Get access

Take a look at the most sophisticated solution developed specifically for medical devices and IVD.

1. Discovery Call | 2. DEMO | 3. Workspace Setup

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No credit card required

The fastest and easiest way to digitalize your
RA & QA

See the DEMO