Ocupharm Diagnostics helps in the preparation – total or partial – of the technical files, carrying out the design and technical file of ophthalmic health products under the regulations;
- (UE) 2017/745
- (UE) 2017/746
The medical device technical file is the set of documents that contain the product specifications and requirements.
The technical documentation of the product, or the technical file of a medical device, must be prepared by the manufacturer in a clear, organized, easy-to-search and unambiguous manner, including, at least:
- Product description and specifications, including variants and accessories.
- Information to be provided by the manufacturer (label and instructions for use).
- Design and manufacturing information.
- General safety and operational requirements.
- Risk management.
- Product verification and validation.
The basis and content of the Technical File is regulated by the harmonized legislation and regulations that apply to it, collecting all the information related to the product, from its earliest design phases to the legislatively required post-marketing monitoring. As an essential element of the technical file, the list of general safety and operating 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.