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The Significance of Requirements Documentation for a Medical Device

    a person using an oximeter, representing The Significance of Requirements Documentation for a Medical Device

    In the medical device industry, proper requirements documentation is crucial in the early stages of development. A requirements document outlines the purpose, features, functionality, and behavior of a medical device. This document provides the guidelines for the development and manufacturing process of medical devices. As the development process begins and features of a medical device change, the requirements documentation should be adequately updated to provide the FDA with the clear functionality of the device. A well-written and consistently updated requirements document can help in the FDA approval process as a company is required to show to the FDA that their medical device is safe, effective, and operates as specified. 

    A thorough requirements document allows for all teams in the development process, from engineers to project management to marketing, to be on the same page and understand their roles. Apart from being comprehensive, this documentation must also be incredibly specific as to the functions, features, and uses of the device. Specificity helps the design and development teams know what the device is intended for and thus how to create it and it helps the FDA verify that the medical device has been created as intended. A simple way to speed up the FDA approval process is to make sure that your company has the appropriate requirements documentation early on as this documentation takes into account what the FDA is looking for. 

    Given that this documentation will be used by a variety of different teams in the development process it is important that the requirements documentation is written in a language that is accessible to all. For instance, usage of too much medical and technical jargon may be understood by the engineers but it would be difficult for other development teams to decipher the language. For this reason, it is crucial to have the right type of writer or writers to produce this document. Technical writers have the experience and the ability to make this kind of documentation easily understandable by all involved in the development process. 

    Types of Medical Devices 

    The FDA classifies medical devices into three different categories: Class I, II, and III. Class I are the low-risk medical devices including surgical masks, bandages, and non-electric wheelchairs. Most medical devices are classified as Class II, which are moderate-risk medical devices that include syringes, blood pressure cuffs, and catheters. Class III medical devices present the highest risk to patients and include implantable pacemakers, defibrillators, and cochlear implants. Evidently, the FDA approval process timeline varies in length depending on the type of medical device, with a much longer approval process for Class II and III devices. With the appropriate requirements documentation, your company can cut down on the approval timeline as it helps prepare for the submission process. This documentation serves as a sort of checklist that will help your company have a successful submission. 

    Features of Medical Device Requirements Documentation

    Although there isn’t a standardized format for a requirements document, they all need to outline a medical device’s ​​function, behavior, and performance. Additionally, the requirements outlined must be able to be tested to prove whether they are correct or whether they need to be updated. For instance, the user-friendly quality of a medical device might be thought of and documented in one way but if it changes then this can be updated simply in the documentation to keep track of the device’s functionality. Among the sections that should be included in requirements documentation is: 

    • Features
    • Intended market
    • User needs 
    • Regulatory compliance 
    • Performance 
    • Safety and risks 
    • Instructions for use requirements 
    • Labeling 

    These sections are intended to not only guide designers and engineers but also help with documentation that will then be required in the FDA approval process. 

    Any company that wants to take their medical device to market, must submit a 510(k) to the FDA. The 510(k) is a premarket submission that shows that a company’s medical device is as safe and effective as an already legally marketed device. This submission process requires documentation on the intended use of the medical device, description of the device, performance testing, and information on sterilization, among other factors. In this instance, the requirements documentation can be quite useful in submitting a 510(k) as it covers the information required by the FDA. It is important to continually update requirements documentation throughout the development process so the data and information stored in this documentation can be used for the submission of the 510(k). Evidently, this means that this document should be written up early in the process and maintained by a competent and experienced technical writer

    How EDC Can Help 

    Establishing a clear well-documented plan for the development of a medical device is fundamental in the production process and in assuring that the device complies with regulations. Requirements documentation is essential to stay on track for FDA approval as it answers many of the questions the FDA will need to know in the submission process. Given that this document will need to be written for technical teams and design teams, it should be written in a common language so everyone is on the same page. In this regard, hiring a technical writer can help produce and update requirements documentation and write it in a language that is understood by all involved. EDC’s technical writers are well adept at producing this type of documentation. They have decades of experience creating scientific, medical, and financial technical writing, including user guides, training materials, and standard operating procedures

    ​​Whether you need a team of consultants to produce a complete line of documentation or a single technical writer for a brief project, Essential Data’s Engagement Manager will lead the project from start to finish. At Essential Data Corporation, the quality of our work is guaranteed. Contact us today to get started. (800) 221-0093 or sales@edc.us

    Written by Diana Guerra

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