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Ing to the MDR, the technical file is a mandatory document for all types of medical devices that has to be prepared in a clear understandable language and must be well-organized and readily-searchable. It is essential to demonstrate the safety and performance of a specific device.

The 5 Necessary Steps for Medical Device Commercialization #1. Regulatory pathway. #2. Reimbursement strategy. #3. Connectivity strategy. #4. Quality management system (QMS) #5. Cash-flow to support go-to-market.

It can include drawings, specifications, reports, review records, meeting minutes, labels, instructions for use, software source code, production process flow charts, etc.

A medical device technical file is a comprehensive document that contains all the technical information and data related to a medical device, such as design, manufacturing, testing, clinical evaluation, and risk management.

The medical device technical file (now known simply as the medical device file) is a term used in ISO 13416. It refers to the technical documentation required by ISO and your regulator to prove your product currently meets all performance and safety standards.

The Difference Between a Technical File and a Design Dossier Technical files, sometimes referred to as technical documentation, are required for all Class I, Class IIa and Class IIb medical devices. Design dossiers refer to the technical documentation for Class III devices.

To get FDA approval for your medical device, you'll need to go through the following five steps. Know Your Device's Classification. Medical devices fall into three classes: ... Develop a Prototype. ... Submit Your Applications (If Applicable) ... Wait for FDA Review and Approval. ... Maintain FDA Compliance.