CHF6,600.00
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This package includes a review of your quality management system according to ISO 13485 including approximately 40 hours of review time. We can provide you with a documented review including suggested improvements to help improve your chances of obtaining your ISO 13485 certificate.
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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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