You want to import, trade and/or sell your machinery on the European market? You want to do this according to the legal requirements to avoid problems at customs or to decrease liability? We have developed a video course that instructs you on how to create a compliant user manual.
The IFU Medical Devices template is an MS Word template, that contains all mandatory elements to create your own IFU for a medical device. You can use the template to create IF that complies with the CE marking requirements, the Medical Device Regulation/Medical Device Directive, the EN 82079 standard for User Instructions and the ANSI Z535.6 for Safety Messages.
The package contains:
The user instructions 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.
With this template, you assure compliance with:
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 are convinced it will not come to that.
We notify you if there are regulatory changes pertaining to your product
We ensure the availability of the technical file in case of requests from authorities
We represent you on your behalf for all legal issues pertaining to your product
You gain access to the EU/UK market, no matter where your business is located
We register as your official point of contact for market surveillance authorities
Trust us as your partner to verify the compliance of your products
With over 25 years’ industry experience, our team can provide expert guidance
on every aspect of product compliance.
We offer custom training programs led by experts, bringing your team up to
speed with important safety processes and regulations related to your markets.
Make sure your manuals, labelling and packaging are fully compliant with your
chosen markets. From writing to reviewing materials, we’ve got you covered.
We help you eliminate risks more efficiently, protect your customers and your business. Unsure whether you’ve done something correctly? We can provide a full risk assessment evaluation.
We create a clear and practical compliance roadmap for you in any market. Get expert guidance on cost/time efficiency of certification for accessing multiple markets.
Wherever you’re located, we offer a wide range of expert testing and inspection capabilities, both in house and via our global network of affiliated partners and testing laboratories.
We review your designs and assist you through the prototype phase to ensure critical safety standards are met.
Every manufacturer requires a technical file to reach compliance. We support, compile and review these technical documents for you.
We provide Authorised Representation (AR) for businesses and e-commerce companies located outside the EU/UK – allowing access to those markets by registering us as your legal partner.
Enter any market, no matter the marking or industry. From CE marking and UL to CCC, we offer complete certification guidance and expert services tailored to your unique situation.