Confidence Beyond Compliance

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Frequently Asked Questions

  1. Is the product we are developing a medical device?
  2. How do we determine the classification for our device?
  3. Can we utilize the 510(k) regulatory pathway for US market authorization?
  4. How do we register our facility and list our products with the FDA?
  5. What is required to be on product labeling?
  6. Do you provide services for U.S. Agent/Offiical Correspondent?
  7. How do we prepare for an FDA inspection?
  8. What procedures are needed to implement a compliant quality system?
  9. What is the best approach for complying with new EU MDR requirements?
  10. What is the best way to respond to an FDA 483 and how do we address remediation?