Ocupharm Diagnostics S.L assists in the complete or partial preparation of technical files, designing and preparing the technical dossier for ophthalmic medical devices under the regulations:
The medical device technical file is a collection of documents that contain the product specifications and requirements. The technical product documentation, or medical device technical file, must be prepared by the manufacturer in a clear, organized, easy-to-search, and unambiguous manner, including at least:
The foundation and content of the technical file are governed by the legislation and harmonized standards that apply to it, encompassing all the information related to the product, from its earliest design stages to the legislatively required post-market surveillance. As an essential element of the technical file, the list of general safety and performance requirements is documented. It is the responsibility of the technical manager to maintain and preserve this information, making it available to the competent authorities when required.
