Achieve Fast Compliance with FDA 21 CFR PART 820

FDA 21 CFR PART 820 Solution Benefits:

  • Adhere to FDA Quality Systems Regulations
  • Secure funding by quickly achieving FDA compliance
  • Support the QA team to work with FDA 21 CFR Part 820
  • Manage components from many different suppliers
  • Ease maintenance of Design Controls and Design Documents

Traditionally, to achieve FDA 21 CFR Part 820 compliance, you would labor through mountains of paper documents and disparate digital information, or invest in costly Document Management Systems. With Polarion you can create a Document History File (DHS) – including forensic level traceability – in minutes, and satisfy any audit.

How to Achieve FDA 21 Part 820 Compliance with Polarion

Our customers have recently discovered that using Polarion software for FDA 21 Part 820 compliance allows for utilizing smaller teams and deliver quicker results, with cost savings of between 35% to 50%.

FDA 21 CFR PART 820 Solution Highlights:

  • Accurate traceability for all artifacts throughout the entire lifecycle
  • Intuitive interface increasing end user acceptance and productivity
  • Out-of-the-box templates and processes can be easily customized
  • Real-time monitoring and reporting of defects
  • Fully traceable management of product complaints and adverse events
  • Automated routing, approval and incorporated escalation for overdue tasks
  • Increased management oversight through advanced analytics and reports

Michael Dalpiaz | Sirona Dental Systems

Customer Success Story Sirona

“Sirona Dental Systems uses Polarion to achieve compliance with medical device regulations like FDA or IEC 62304.”



Rafi Heumann | LifeWatch COO

Customer Success Story Lifewatch

"Polarion provides the foundation for submitting for FDA Clearance"

Learn More About Polarion for Medical Devices

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