Regardless of a device class, or its intended use, design, or even the safety history of the device, the manufacturer must. Annex II and III of the EU medical device regulation (MDR) and of the In-vitro Diagnostic Regulation (IVDR) contain an overview of the contents and structure of a technical file, here called Technical documentation. A medical device technical file is a summary document prepared by the manufacturer in a clear, well-organised, readily searchable, and unambiguous manner to demonstrate the safety and performance of the specific device. The sub-clause 4.2.3 of ISO 13485:2016 requires a manufacturer of a medical device to establish a technical file ( medical device file, device master record, design dossier, or device master file). A technical file is a set of documents that describes a product and can prove that the product was designed in accordance with the requirements of a quality. One document may be named "technical file" and list all other documents that are considered part of the technical file but it can be made available to the competent authority on request. This terminology is used by the MTE Ad Hoc Group on PP to distinguish the Procedure packs documentation from the technical documentation/technical file of the original manufacturer.
#TEXNICLE FILE SOFTWARE#
It can include drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, production process flow charts, etc. Procedure pack file: PPF documentation to support compliance with MDR Article.22.1 -22.3. Bellino Srl active for 30 years in the field of precision mechanical processing, designs, manufactures and assembles regulation valves and equipment for.
#TEXNICLE FILE ARCHIVE#
A technical file is usually based on a document archive system that ensures longevity of documents and can either be on paper or in electronic files. For the MDR, IVDR and Australian applications, one of the requirements is to create a technical file that contains all the information or technical.
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