Template Medical Devices for the U.S.

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!