EU CE Mark and FDA 510(k)

Our expert team will prepare and submit your 510(k) to FDA for clearance

For EU CE Mark Certification or FDA 510(k) Submission we will…

  • Evaluate your medical device description and intended use to determine your medical device’s product classification
  • Identify EU and FDA Recognized Consensus Standards that apply to your product (such as Electrical Safety and Biocompatibility), and any product specific FDA Guidance Documents
  • Recommend the optimum predicate device to compare your device‚Äôs performance when developing the 510(K)
  • Write and assemble your Technical File or 510(k) submission using your technical documentation
  • Provide consulting services and project management services by coordinating with third-party test houses for Consensus Standards testing, reviewing deliverables, and augmenting your resources for developing the software design documentation necessary for EU CE Mark Certification or 510(k) submissions
  • After you review and approve the 510(k) draft, we will submit it in your behalf to FDA
  • We will also help you find a Notified Body for CE Mark certification