Purpose Built For 8+ Connectors

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Features & Benefits

We Have All The Tools You Need To Prepare For Eudamed Compliance

Gain full visibility into EUDAMED data requirements

Go-live and submit your data to EUDAMED from September 2021.

Train and test your staff in Innovit’s EUDAMED’s playground environment

Gather and validate your BUDI and UDI data

Data quality review & approval processes systemized

UDI knowledge & expertise at your Fingertips

Self-paced learning of EUDAMED UDI concepts with online audio-visual tutorials.

Pre-packaged EUDAMED data validation in real-time, on-screen and on-demand.

System is 100% cloud-hosted, fully-maintained and automatically backed-up.

Updated automatically with the latest EUDAMED business rules, data dictionary & enumerated code lists.

Out-of-the-box review & approval workflow for data maintenance & submission.

Intuitive, process-driven and modern browser user interface and UX.

Compare features

Select the product suite that fits your needs
MDM.Cloud
26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.
GDSN.cloud
26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.
EUDAMED.Cloud
26 May 2021 marks the start of transition arrangements from the former Medical Device Directive (MDD) to new Medical Device Regulation (MDR) until 26 May 2024.
Features
StarterFree
intermediate$150
Advanced$300
Professional$500
StarterFree
intermediate$1800
Advanced$3600
Professional$6000
Validation & Maintenance
  • Manage & validate NPC data with real time data validation, bulk update capabilities and validation reporting.
Regulatory Data
Manage Regulation Device Data
  • Basic UDI-DI & UDI-DI (MDR, IVDR)
  • Legact Device Data (MDD, IVDD, AIMDD)
Search and Query line
  • powerful search tools with our Query Line and simple search option
Import & Export
  • Standard templated Data Import/Export
Excel/CSV Excel/CSV Excel/CSV Excel/CSV
  • Scheduled data import from source systems
Workflows Learn more
  • Pre-configured 2-Step review & approval workflow
  • Configurable scheduled M2M data upload & publication
Support Learn more
  • Access to online audio-visual training & tutorials
  • Online user forums for knowledge sharing
  • Chat support sessions btween business hours
  • live phone support
Licencing volumes
item records 100 records 250 records 500 records 1,000 records
named users 4 users 4 users 6 users 10 users
Supplier GLNs 1 supplier 1 supplier 2 supplier 2 supplier
Hosting Learn more
Public cloud available available available available
Private cloud available available available available
Hybrid cloud available available available available
ACTIVATE TRIALACTIVATE TRIAL
Features
$150
$150
$300
$500
$1800
$1800
$3600
$6000
Validation & Maintenance
  • Manage & validate NPC data with real time data validation, bulk update capabilities and validation reporting.
Regulatory Data
Manage Regulation Device Data
  • Basic UDI-DI & UDI-DI (MDR, IVDR)
  • Legact Device Data (MDD, IVDD, AIMDD)
Search and Query line
  • powerful search tools with our Query Line and simple search option
Import & Export
  • Standard templated Data Import/Export
Excel/CSV Excel/CSV Excel/CSV Excel/CSV
  • Scheduled data import from source systems
Workflows Learn more
  • Pre-configured 2-Step review & approval workflow
  • Configurable scheduled M2M data upload & publication
Support Learn more
  • Access to online audio-visual training & tutorials
  • Online user forums for knowledge sharing
  • Chat support sessions btween business hours
  • live phone support
Licencing volumes
item records 100 records 250 records 500 records 1,000 records
named users 4 users 4 users 6 users 10 users
Supplier GLNs 1 supplier 1 supplier 2 supplier 2 supplier
Hosting Learn more
Public cloud available available available available
Private cloud available available available available
Hybrid cloud available available available available
Features
Starter$150
intermediate$150
Advanced$300
Professional$500
Starter$150
intermediate$1800
Advanced$3600
Professional$6000
Validation & Maintenance
  • Manage & validate NPC data with real time data validation, bulk update capabilities and validation reporting.
Regulatory Data
Manage Regulation Device Data
  • Basic UDI-DI & UDI-DI (MDR, IVDR)
  • Legact Device Data (MDD, IVDD, AIMDD)
Search and Query line
  • powerful search tools with our Query Line and simple search option
Import & Export
  • Standard templated Data Import/Export
Excel/CSV Excel/CSV Excel/CSV Excel/CSV
  • Scheduled data import from source systems
Workflows Learn more
  • Pre-configured 2-Step review & approval workflow
  • Configurable scheduled M2M data upload & publication
Support Learn more
  • Access to online audio-visual training & tutorials
  • Online user forums for knowledge sharing
  • Chat support sessions btween business hours
  • live phone support
Licencing volumes
item records 100 records 250 records 500 records 1,000 records
named users 4 users 4 users 6 users 10 users
Supplier GLNs 1 supplier 1 supplier 2 supplier 2 supplier
Hosting Learn more
Public cloud available available available available
Private cloud available available available available
Hybrid cloud available available available available
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ENTERPRISE SUITE

What our customers are saying

What our customers are saying

“We were at risk to miss the UDI Class II deadline of September 2016 and our team in Australia suggested Innovit. After an extensive RFP process involving numerous solutions, the path forward was clear.”

“Within eight months from project kick-off, we were able to submit data to the FDA’s GUDID system, meeting the GDSN MJR3 May 6th deadline.”

“We were at risk to miss the UDI Class II deadline of September 2016 and our team in Australia suggested Innovit. After an extensive RFP process involving numerous solutions, the path forward was clear.”

“Within eight months from project kick-off, we were able to submit data to the FDA’s GUDID system, meeting the GDSN MJR3 May 6th deadline.”