A medical device technical file is an extensive doc that contains all essential information about a medical device, demonstrating its safety, general performance and compliance with relevant regulations.

Even though the relevant laws establishes what should be within a technical file, and therefore the technical file of a toy is different from that of equipment, you will find sure components that overlap.

“Each producer shall set up and maintain a DHF for every sort of device. The DHF shall incorporate or reference the information essential to demonstrate that the look was produced in accordance Together with the accepted design designs and the necessities of this portion.”

In lieu of retaining several copies of such paperwork in separate folders for each regulatory submission, the corporate can employ just one electronic document that's associated with several archives.

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A Notified System or regulatory authority audits the file to ensure the device satisfies security and general performance criteria. The device’s manufacturer is chargeable for keeping the technical file and ensuring it fulfills all lawful and regulatory specifications, with certification granted to the device alone.

This e-book compares the top QMS application remedies to assist medical device businesses make an educated conclusion when buying a high quality administration process.

Each and every technical file should consist of information on the design of your item. An item can be described applying words or employing drawings. The sections down below give an overview of the most typical means to describe an item. 

What This implies is always that importers generally have to develop their particular technical documentation, whether or not this is simply not laid out in the directive or regulation.

Packaging info ought to demonstrate the device’s packaging maintains its sterility and guards it through transport and storage. This could include things like packaging content specs, test benefits and packaging structure documentation.

Along with that, requirements exist regarding the UDI-DI in case of reusable surgical devices, or implantable, so this code selection is well obtainable in all situations.

These changes Technical File should be captured in actual time, Therefore the file continues to be a trustworthy history within your protection and performance position.

An all-in-1 compliance Resolution encouraging you study appropriate product or service protection specifications from the United states of america and EU. You can also access a library of merchandise certificate and label templates, e-book lab testing, and request queries.

SimplerQMS supplies completely validated eQMS for medical device businesses to streamline high-quality management procedures and good quality documentation management, including the administration of technical documentation.