E-IFU Smart Solutions for Medical Device & Pharma

WE ARE REGULATORY EXPERTS

WE PROVIDE AN INNOVATIVE TOOL TO MANAGE YOUR IFU DIGITALLY AND IN FULL COMPLIANCE WITH MDR REGULATION.

HUGE Cost Saving by implementing Our solutions

What does your company spend on packaging, paper, printing, logistics and the management of all that? You can send that to zero!

e-IFU Platform PLATFORM FEATURES:

• Web App
• Dedicated back end to manage documentation
• Revision management
• Guarantee that only approved templates and content are used with version control
• QR scan and download
• Personalized front end
• Language management
• Product family grouping
• Multidocuments management
• Local language self-recognition
• Blockchain Audit Trail
  
  

 Compliant Solution

Our software solution is compliant to: FDA part 11, ISO 27000, IEC 62304, MDR and IVDR.

Key Benefits:

• Save on printing and managing all related paper process

• Developed by Regulatory Compliance Experts

• Organize all your instructions for use and make them

• available to your customers

• DON’T BREAK THE SEAL - review product documentation without having to break your product's seal.

• Tamper Proof via blockchain

• Audit trail compliant to 21 CFR Part 11 on Blockchain

• Quick and easy retrieve via QR code Scan

• From an off-the-shelf solution to a fully tailor-made platform