EU CE Mark and FDA 510(k)

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’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 in your behalf to FDA
• We will also help you find a Notified Body for CE Mark certification