SafetyEasy Device

The Medical Device Vigilance Software

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

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MedDEV XML & HL7

SafetyEasy MD is HL7 MEDDEV XML fully compliant.

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Full MedDRA services

Automatic recoding and SMQ

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Integrated BI solution

Business Intelligence tool integrated

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WorkFlow integrated

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

Compliance

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

Validation

  • 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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