Digital FDA Submissions

Key Takeaways

Propel's Digital FDA Submissions allow medical device manufacturers to:

• Gather product and case information directly from existing product and quality records
• Electronically create, submit, and track progress with MedWatch Form FDA 3500A submissions
• Record and integrate FDA communications with existing audit trails
• Improve process efficiencies and audit readiness

About This Resource

Digital FDA Submissions allow medical device manufacturers to electronically create, submit and track progress with MedWatch Form FDA 3500A submissions directly through the Propel platform. Submissions and audit trails are fully integrated with product and quality capabilities, improving accuracy while streamlining the process.