SafetyEasy Device

The Medical Device Vigilance Software

The Medical Device Vigilance software fully dedicated to the management of Adverse Event related to Medical devices.



SafetyEasy MD is HL7 MEDDEV XML fully compliant.


Full MedDRA services

Automatic recoding and SMQ


Integrated BI solution

Business Intelligence tool integrated


WorkFlow integrated

A fully customizable workFlow is integrated with SafetyEasy. It can be modified to follow with ease your company organization.


  • European & Worldwide Regulations compliance
  • FDA 21 CFR part 11 designed
  • Softwares contractually updated


  • GAMP 5 validation
  • On-line valdation dossier available
  • Validation dossier updated
  • Minimum validation effort

Full services

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

Secured & Reliable

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

Fast & User Friendly

  • Full web (pure HTML)
  • All web browser compatibility
  • Customization available
  • Easy and fast Data Entry
  • Fully customizable WorkFlow

Fair pricing

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

SaaS & On-Premise

  • Hosted solutions
  • On-Premise solution
  • SaaS vs On-Premise
  • Great experience in data migration

Scalable & Flexible

  • Full Query module integrate
  • Totally customizable by end users
  • Fully customizable Work Flow

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