IFU Template Medical Devices for the U.S. Market

The IFU medical device template is an MS Word template, that contains all mandatory elements to create your own Instructions For Use (IFU). You can use the template to create the IFU that complies with the requirements of the FDA's CFR Regulations (21 CFR 801.5 - MEDICAL DEVICES; ADEQUATE DIRECTIONS FOR USE), the 'Guidance on Medical Device Patient Labeling; Final Guidance for Industry and FDA Reviewers', the IEC/IEEE 82079-1:2019 for Informatiom for Use, and the ANSI Z535.6 for Safety Messages.
Essential user manual template for all manufacturers, importers and distributors that trade medical devices within the United States to pass customs with no delays, be able to sell your medical devices within the US and decrease liability. You want to import, trade and/or sell your medical devices on the U.S. market? You want to do this according to the legal requirements to avoid problems at customs or to decrease liability? We have developed an IFU medical device template to make it happen. A lot quicker and easier than you ever imagined.
  • Gain confidence when selling your medical devices on the U.S. market
  • Learn how to create compliant Instructions For use with a template for your medical devices
  • Finally, all relevant regulations made practical without the need to sort everything out yourself
NOTICE The IFU template does not comply with any product specific requirements, as may be required by mandatory or voluntary product standards. For example, the template does not contain the legal content for electrical toothbrushes as mentioned in ISO 20127:2005 Dentistry -- Powered toothbrushes.

Create your own US manuals

  • Achieve compliance with the Code of Federal Regulations for User Instructions for Medical Devices
  • Sell your medical devices on the US market
  • Decrease liability
  • Save costs
  • Well-thought-out and easy to use
  • More grip on the quality of your manuals

What will the IFU Template help you to achieve?

  • Compliance with the Code of Federal Regulations for User Instructions for Medical Devices (for the U.S. market)
  • IEC/IEEE 82079-1:2019 for Informatiom for Use compliance
  • ISO 3864 and ANSI Z535.6 compliance

CFR compliance

The function of the Instructions for Use is to explain to the user how a product can be used safely and correctly, according to its intended uses. The IFU informs the user about risks that still persist, despite the adoption of measures for inherent safe design, safeguarding and complementary protection. Failure to warn the user properly can make the manufacturer liable in case of any accidents. That’s why the duty to warn/provide instructions with the products is regulated and often mandatory. The IFU Medical Device Template for the U.S. is a MS Word file that contains all mandatory elements, as required by the Code of Federal Regulations for Medical Devices, section 801.5 Adequate User Instructions for Medical Devices.

IEC/IEEE 82079-1:2019 compliance

The IEC/IEEE 82079-1:2019 for Information for Use  is an international standard that provides both general principles and detailed requirements for the design and formulation of all types of user instructions. The IFU Medical Device Template for the U.S. contains all elements as provided by the 82079 that can be easily adjusted to your own needs. The table of contents of the IFU Medical Device Template is based on the content requirements as given by this internationally recognized standard.

ISO 3864 and ANSI Z535.6 compliance

The ISO 3864 standard specifies international standards for safety symbols, including the formatting of the DANGER, WARNING, CAUTION safety symbol panels. The ANSI Z535.6 also describes the formatting of these, but also gives requirements on when to use which warning level, where to place safety messages throughout the manual and how to use words like shall, could and may. The IFU Medical Device Template for the U.S. has adopted the requirements from this standard, so you will be able to create compliant safety instructions.

Money Back Guarantee

All our templates have a 14-day, no-reason-required guarantee. So if you are not satisfied for any reason, just let us know, and we’ll refund your money. As we believe that our product really helps you to create better instructions, we don’t think it’ll come to that. But as soon as you have any doubts whether our product is the right fit for you, just put your mind at ease. We will help you to get the results you want, or we will give you your money back!

IFU Template Medical Devices for the U.S. Market

$597

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Frequently Asked Questions

The template is an MS Word file. To open our files you need Microsoft Word.
Yes! All our packages have a 14-day no-reason-required guarantee. So if there is any reason that you are not satisfied, just let us know and we’ll refund your money. As we think that our product really helps you to create better documentation, we don’t think it’ll come to that. But as soon as you have any doubts whether our product is the right fit for you, just put your mind at ease. We will help you to get the results you want, or we will give you your money back!
You can find the following important information on our website:
  • General business terms and conditions
  • Revocation statement
  • User manual template disclaimer
  • Website privacy policy
No! The User Manual Template is a tool that will HELP you to create compliant manuals. We will tell you what elements should be in the manual, how to comply with directives and standards and even provide you with ready-to-use legal texts, but in the end you are responsible for full compliance. There are hundreds of thousands of different products out there and they all come with different risks. So it is impossible to create a template that includes all warnings for all products for example. However, we do tell you HOW you should include your specific product information in order to achieve compliance. Besides that we have included many elements for the main product groups and requirements from standards like the ANSI Z535.6 and IEC/IEEE 82079-1:2019.
As soon as your payment has been completed, you will receive an email with a link to the download page. If you haven’t received an email after some time, please check your spam folder and junk mail. It might be in there! If you haven’t white listed us yet, please make sure you do so if you want to receive our updates on legislation changes, sample instruction manuals and other relevant stuff.
Legislation is subject to improvement and technological progress. That’s why safety standards and/or directives are being updated every now and then. Once part of our community, we send you updates on relevant changes.

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