510K Filing

Most commercial medical devices sold in the United States require a 501(k) submission, proving that the device is at least as safe and effective or substantially equivalent to a previous device.

Realistic Quality Solutions can help:

• Access and identify substantially equivalent 510(k) devices.
• Prepare responses to FDA questions
  
• Identify FDA guidance materials
• Detail special FDA requirements that might impact the review of a 501(k) filing.
• Prepare and submit 510(k) documents to the FDA.
• Coordinate communications and negotiations with the FDA.

SUBMIT A REQUEST FOR INFORMATION