Medical Device Standards Management

Automatically and proactively monitor and manage global standards.

Never be out of compliance with state-of-the-art standards. Improper standards management causes major delays in time-to-market, resulting in budget and project schedule overages. Without an automated process for standards management, regulatory affairs professionals run the risk of audit nonconformities and knowledge gaps during employee turnover.

Automatically and proactively monitor and manage changing global standards.

  • 500,000+ standards from 200+ Standard Development Organizations (SDOs)
  • Associate standards to products for easy reporting and impact assessments
  • Receive timely notifications of superseded, withdrawn, and work-in-progress standards

500,000+ standards

from 200+ Standard Development Organizations (SDOs)

Rimsys Standards Module

How Rimsys Helps with Standards Management

Track any medical device standard, anywhere, anytime.

Step 1

Search Standards

Search through our database of 500,000+ standards.

Step 2

Add Standards to Your Own Library

Add them to “My Standards Library” where you can keep track of any changes.

Step 3

Link Standards

Link standards to your products to build a comprehensive regulatory standards database.

Step 4

Get Notified

If a standard changes, receive notification of those changes, determine impacted products and quickly identify associated technical files.

Schedule a Demo Now

Get Free Demo

Integrates Seamlessly into our other solutions

Medical Device Product Registration

Monitor and manage global registrations and regulatory applications.

Medical Device UDI Software

MedTech UDI software that is fully integrated and automated to a product's registration lifecycle

Medical Device Standards Management

Automatically and proactively monitor and manage global standards.

Medical Device Essential Principles/GSPR

Digitally create, manage, and maintain all Essential Principles.

Medical Device Regulatory Intelligence

Track changing laws, regulations, guidance documents, and relevant news.