Why Do Companies Use Medical Device Technical Files? What are they Used for?
A medical device technical file describes how a medical device works, what it looks like, and how it should be used. The file also includes instructions for manufacturing the device, which include information on materials, processes, tools, and equipment needed.
What Are Medical Device Technical Files Used For?Medical device technical files are used by companies to communicate with each other about their devices. They help ensure that everyone knows exactly what the company is producing and how it should be manufactured.
Types of MDTFThere are three main types : 1) Product Description File (PDF), 2) Manufacturing Information File (MIF), and 3) Quality System Manual (QSM).
Benefits of Using Medical Device Technical FilesThese documents help companies comply with FDA regulations and ensure quality control. They also provide information about the product to customers and other stakeholders.
Examples of MDTF Used By ManufacturersThere are several different types of medical device technical files. One type is called an "Operator Manual." This is a manual that describes how to use the product. Another type is called a "User Guide." This is usually a booklet that provides instructions on how to operate the product.
What Are Medical Device Technical Files?These documents are often used by companies when they are developing new products. They also provide information to doctors who will be using the product.
Medical Device Technical File (MDR)Want to prepare a mdtf as per the requirement of MDR 2017/745? If your answer is yes, you probably have lots of questions about the preparation of medical device technical files such as;
What shall be covered in the medical devices technical file?Which Annex of -MDR 745/2017 shall be referred for the preparation of medical device technical file according to MDR?
Who will review and approve this file?We at Maven Profcon Services LLP, shall give you all the answers.
Maven as a developing medical device regulatory consultancy helps you in establishing your products in various countries with help of our experienced regulatory consultants. The below mentioned activities are taken care by us
1. Gap analysis as per the requirement of EU-MDR2) Identification and classification of the medical device as per EU MDR3) Help in selection of conformity route of assessment and Notified body4) Preparation and Review of the technical documents as per EU MDR.5) Help to maintain and update the technical file post certification.