Medical Device

MEDICAL DEVICE LABELING

We help our customers to achieve the most rigorous demands of labeling compliance: FDA 21 CFR Part 11, EU MDR, FDA UDI , FDA 21 CFR 820; to increase their operational efficiency through a single source of truth and to maintain their data integrity.

There is only one labeling solution dedicated to the medical device industry. It was designed in conjunction with industry leaders and customer user groups including Boston Scientific, Zimmer and Stryker.

Please watch our Medical Device video:

 

We save our customers millions every year:

  • $10M of recalls prevented
  • 175 tons of paper waste eliminated
  • $19M saved in error prevention
  • $8M  saved with ‘Just in Time’ labeling

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CHOSEN BY THESE CUSTOMERS...

PRISYM 360 MEDICAL DEVICE DEPLOYMENT OPTIONS

SaaS
Medical Device
  • Cloud based compliance ready end-to-end label management and control
  • Scalable depending on the size of organizations and their requirements
  • Fully GxP qualified cloud platform and application software, delivered with validation pack
  • Rapid deployment
  • Centralized data storage

Suitable for all sizes of organizations from start-ups to growing companies with multiple sites to large scale, multi-site operations.

On Premise
Medical Device
  • Full functionality of PRISYM 360
  • Ability to control your labels end to end
  • Integrations with ERP, PLM, MES systems
  • Vision inspection
  • Mass Change tools
  • Regulatory Rules
  • Blue Prints
  • Professional Services

Designed in partnership with our customers, it is truly the benchmark for validated labeling applications in Life Science.

Private Cloud
Medical Device
All the features of On Premise +
  • Dedicated Private Cloud environment
  • Cloud provider specializing 100% in Life Sciences
  • Strict compliance with GxP practices
  • SSAE 16 SOC Type II and ISO 27001 / 14001 certified Security processes
  • Offsite data backup and Disaster Recovery
  • Full managed service options

Addresses the need for organizations that do not want to be responsible for managing the infrastructure or on-going maintenance.

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MEDICAL DEVICE LABELING RESOURCES

Developing 2020 Vision Will Your Labeling Strategy Assure Compliance with EU MDR Developing 2020 Vision: Will Your Labeling Strategy Assure Compliance with EU MDR? Posted in: Achieving Regulatory Compliance, Medical Device, Regulatory & Compliance, Whitepaper -

The European medical device industry is a third of the way into a 3-year transitional period that will culminate with full implementation of EU MDR.

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PRISYM ID Recalls E-book How to Avoid Four Common Labeling Product Recalls Posted in: Achieving Regulatory Compliance, Increasing The Operational Efficiency, Medical Device, Operations & Labeling, Project Managers, Regulatory & Compliance, Whitepaper -

Companies’ continued reliance on manual processes and disparate labeling systems often culminates in pricey product recalls.

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