Product Details:

Essential instruction 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 a user manual 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 a compliant manual with a template for your medical devices
• Finally, all relevant regulations made practical without the need to sort everything out yourself

NOTICE The user manual 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 User Manual Template help you to achieve?

• Compliance with the Code of Federal Regulations for User Instructions for Medical Devices
• IEC 82079 – User Instructions compliance
• ISO 3864 and ANSI Z535.6 compliance

CFR compliance

A user instruction’s function is to explain to the user how a product can be used safely and correctly. The user manual 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 User Manual Template 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 82079 compliance

The EN IEC 82079-1:2012 Preparation of instructions 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 standard has been harmonized by the EU, which means that by applying the standard you create the highest level of presumption of conformity with the Essential Requirements of the Directives. The User Manual Template contains all elements as provided by the 82079 that can be easily adjusted to your own needs. The table of contents of the User Manual 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 User Manual Template 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!