SafetyEasy MD


The Medical Device Vigilance Software
Fully dedicated to the management of Adverse Events related to Medical Devices.


SafetyEasy MD is HL7 fully compliant and supports eMDR XML file creation.

Smart MedDRA coding

MedDRA dictionnary coding, enabling easy data analysis. 

Integrated BI solution

Business Intelligence tool integrated

Integrated Workflow

A fully customizable workFlow is integrated with SafetyEasy. It adapts easily to your company’s organization.
Medical Device vigilance software’s Key Features
  •   User friendly Data Entry
  • Medical Device interface
  • MedDRA codder
  • Check duplicate management
  • Attach document
  • Narrative template generation
  • Follow Up Management


  •   MedDRA SMQ
  • Query module intergated
  • Calendar (Submission & Follow-up management)
  • Automatic Mail generation
  • Task Scheduler (Change MedDRA version for exemple)


  •  MEDDEV, MedWatch, MIR…
  • eMDR XML HL7 Export
  • Form 5, Form 6
  • DSUR Summary tabulation & Line Listing


  •  Full WorkFlow management
  • Users administration
  • User’s group rights management
  •  Synchronization with SafetyEasy PV for vigilance on products combining PV and MD characteristics (such as injections)

SafetyEasy MD in Numbers

# of Database Installed worldwide

# of cases handled

# of countries

AB Cube safety database are integrated but also:



  • GAMP 5 validation
  • On-line validation dossier available
  • Validation dossier updated with each upgrade
  • Minimum validation effort

Scalable & Flexible

  • Totally customizable by end users
  • Fully customizable Workflow
  • Full Query module integrated

Secured & Reliable

  • HIPAA compliant
  • SSL web access
  • BackUp & Restore
  • 99,99 % SLA guaranteed
  • 21 CFR part 11 Audit Trail
  • ISO 27001 data center (Tiers III plus)

Fast & User Friendly

  • Full web (pure HTML)
  • All web browsers compatibility
  • Customization available
  • Easy and fast data entry
  • Fully customizable WorkFlow

Fairly priced

  • No hidden costs
  • Clear and adaptative offer (From Basic to Professional)
  • Unlimited number of users
  • No additional cost for upgrades

SaaS & On-Premise

  • Pioneer of Hosted solutions
  • On-Premise option available
  • Extensive experience in data migration

With full services

  • Transparency (Access to online Document Management system)
  • eLearning
  • 24 / 7 hotline
  • Validation software
  • Ticketing software

Want more Information about our safety database ?