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’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
