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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