CHF6,600.00
Please read our Terms and Conditions before purchasing.
Alternatively, Contact Us if you need more information! We would be happy to speak with you about your specific needs.
This package includes a review of your complete 510(k) submission including approximately 40 hours of review time. We can provide you with a documented review including suggested improvements to help boost your 510(k) clearance chances.
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We sign a non-disclosure agreement
You provide me with any documentation you currently have (descriptions, research papers, similar product information, design documentation) that can help me better understand your product
We start with a short interview about your product so I can get a quick understanding of how it works (1-2 hours depending on the complexity) and can ask any questions I have based on the material you have sent me
I provide you with a best estimate for my time and we discuss it
I start to write the document and come back to you with questions or requests for more information
I send you a draft and you review it
We conduct a second interview if needed to go over the review, or you pass me your review in written form
We conduct further iterations where necessary…
I deliver you the document
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