EU CE Mark Certification or FDA 510(k) Submissions

Get Approved Easier and Faster

Our Certification and Submission Experts Are Waiting To:

  • 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’s 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 on your behalf to the FDA.
  • We will also help you find a Notified Body for CE Mark certification.
Need help with EU CE Mark Certification or FDA 510(k) Submissions?

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Your journey to a successful regulatory submission and your LEAN Quality System begins here

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