sync it
A perfect connection between Technical Documentation and Quality Management
Digital technical documentation can already do so much more. A synchronized documentation with the QM system sets a completely new standard of compliance.
Meet Meddevo Platform
All in one solution for medical devices
Smart Technical Documentation
Audit & Submission Management
Smart Quality Management
eTD - Electronical Technical Documentation for Medical Devices
Our Mission
“With constantly increasing requirements, Regulatory Affairs has to start working differently.
We finally want to focus on what is essential and important. Less copy & paste and fewer errors in our work.
We believe in higher compliance at lower costs.
We believe in more time for the important issues and more fun at Regulatory Affairs.
If you are tired of dry paperwork and want to take your technical documentation to the next smart level. Then meddevo is for you.”
We finally want to focus on what is essential and important. Less copy & paste and fewer errors in our work.
We believe in higher compliance at lower costs.
We believe in more time for the important issues and more fun at Regulatory Affairs.
If you are tired of dry paperwork and want to take your technical documentation to the next smart level. Then meddevo is for you.”
Michael Kania
founder
Outstanding Workflow
Content
ECM - Enterprise content management for all your product information. From intended purpose, over patient population to GSPRs.
Content Inspector
The meddevo Content Inspector is monitoring your digital technical documentation. Real instant GAP assessment logic with regulatory knowledge.
Documents & Monitoring
meddevo automatically writes your documents and checks them continuously for up-to-dateness.
Automated TechFile
Your technical documentation is automatically generated in your desired format. For example MDR Annex II, US-FDA or IMDRF.
MDR-Ready meddevo cloud
Start your MDR Transition digital with meddevo today
Data Integrity
Safe time
Safe resources
Higher compliance
Automated Documents
Monitored Documents
Automatic GAP Assessment
Designed with the medical device manufacturer in mind
Digitalization for Medical Device Industry
We put your content, processes and documents in one place.
meddevo eTD®
A true digital technical documentation. eTD gives you insight into your medical devices like no other tool. Automatic structures like MDR Annex II, STED or 510k
Inspector
The intelligent GAP Assessment Logic inspects your data in real time. Missing content and complex correlations of requirements are displayed as errors or warnings.
MDR Implementation
Automated MDR GAP indications
Auto-Documents
meddevo automatically writes your evidence documents using digital technical documentation. And monitors the up-to-dateness.
Content and Document Monitoring
The system monitors your content and documents.
EUDAMED Connectivity
From UDI to vigilance. With digital documentation, connectivity to the European database is no longer a problem.
Standard & Evidence Management
Manage your standards and the associated evidence documents at every level of your documentation. At the touch of a button, you are prepared for an audit.
Submission Tracking
Manage your registrations. meddevo shows you deviations from your current documentation.
GSPR Manager
Demonstrate compliance with the General Safety and Performance Requirements. Know immediately if changes occur.
Component Database
Keep a regulatory eye on your bill of materials. Use the data e.g. for biological evaluation and for monitoring.
PMS & PMCF
Bring the market surveillance process to life. As required by MDR. Plan activities and let the system generate reports.
Coming 2020
Coming 2020
Clinical Evaluation Management
Create plans and reports for your clinical evaluation in a smart system. Manage your clinical data in the place where they can communicate with each other.
Coming 2020
Coming 2020
Complaint Management
Benefit from all the advantages of digital technical documentation with integrated change management.
Coming 2020
Coming 2020
Risk Management
A central process that becomes even more important with MDR. Manage risks and link mitigations with the relevant evidence documents.
Coming 2020
Coming 2020
Change Management
Benefit from all the advantages of digital technical documentation with integrated change management.
Coming 2020
Coming 2020
CAPA / Events
The directly linked events and CAPAs give you and the auditor an overview that creates trust with its clarity.
Coming 2020
Coming 2020
SOP & Training
Always up-to-date SOPs and the corresponding training of your employees. Coming 2020
Custom Solutions
meddevo is flexible and dynamic. It is highly configurable and can be extended in a user-defined way.
