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Learn how to develop clear and concise Instructions for Use (IFU) for prescription drug products, including human prescription drug and biological products. The guidance provides recommendations on content, format, page layout, design, and submission of IFU documents.
Learn how to create instructions for use (IFU) for medical devices and in vitro diagnostic products that comply with EU and US regulations. Find out what information to include, how to format, and what standards to apply for IFU.
E-IFU is eligible for medical device intended for use by professional users only. Paper-form IFU is required and additional electronic IFU is optional for home use devices.
This detailed guide gives you a step-by-step breakdown of everything you need to know when creating IFU for medical devices and in-vitro devices – covering both the U.S and European markets. By reading this guide, you’ll gain clarity on: IFU requirements on medical devices and in-vitro devices in Europe and the U.S
Learn how to create and organize the content and format of your IFU for medical devices according to regulatory and ISO standards. Register for the live webinar or purchase the recording and slides.
Nov 9, 2021 · Learn how to write clear and compliant instructions for use (IFU) for medical devices in the US and the EU. Find out the legal requirements, labeling guidelines, and design tips for different types of medical devices.
Mar 28, 2023 · IFU are directions for proper usage of medical products prescribed to patients or used in healthcare settings. Learn about the components, importance, and responsibilities of IFU for manufacturers, vendors, facilities, and end users.
