Want to sell your medical device? If the answer is yes, you probably have a lot of questions about one of the key elements of the regulatory process: Technical File.
Preparing your Technical File takes precision and care, as the requirements for data, documentation, and formatting of this document are very specific. We demystify this important document and answer your biggest questions about how to prepare a Technical File, including:
What is a Technical File/Design Dossier?
Which device classes require a Technical File?
What is the proper format for Technical Files?
In which language to create a technical file?
What are the common elements of a technical file?
What is a clinical evaluation report (CER)?
What is the Declaration of Conformity (DoC)?
Contact us for help building your own Technical File.
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