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The term technical documentation (or technical file) refers to the documents that a medical device manufacturer must submit to the authority before placing it on the market. Completing a technical file is an unavoidable step to pass the conformity assessment or approval process.

Medical Device Technical File Contents Description of the device and specification: In this section, you will include the product or trade name, along with a general description of the medical device. ... Labeling and usage instructions: This section will contain the device labels and their packaging details.

Device. The design history file (DHF) is focused on capturing the history of the design and ensuring that it was done ing to FDA regulation. The device master record (DMR) is focused on building the device and ensuring that all necessary items are included to build, test, package, and service it.

Introduction to Master Files for Devices (MAFs) A premarket approval application (PMA) or an investigational device exemption application (IDE) usually contains data and other information that the applicant has developed and regards as trade secret or confidential commercial financial information.

The medical device file (MDF) is basically what can be referred to the technical dossier, and it is basically the collection of all the data related the medical device in the field.

A device master record (DMR) contains all of the information and specifications needed to produce a medical device from start to finish, including instructions for all manufacturing processes, drawings, documented specifications and labeling and packaging requirements.

The FDA's Medical Device Development Tools (MDDT) program is intended to facilitate device development, timely evaluation of medical devices, and promote innovation by providing a more efficient and predictable means for collecting the necessary information to support regulatory submissions and associated decision- ...

The DMR is the 'recipe' for the safe and successful manufacture of your product, as well as its subsequent product management. It is a required output of your design process. It is the document that you will transfer to production and which they will use to set up and run a compliant manufacturing process.