Product Details
You want to import, trade and/or sell your medical devices 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 an instruction for use template to make it happen.
- Gain confidence when selling your medical device
- Create a compliant manual with this template
- All relevant regulations processed in one template
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.
Compliance
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:
- CE marking compliance
- Compliance with Regulation (EU) 745/2017 for Medical Devices
- IEC 82079 compliance
- ISO 3864 and ANSI Z535.6 compliance
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 are convinced it will not come to that.
Product Details
You want to import, trade and/or sell your medical devices 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 an instruction for use template to make it happen.
- Gain confidence when selling your medical device
- Create a compliant manual with this template
- All relevant regulations processed in one template
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.
Compliance
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:
- CE marking compliance
- Compliance with Regulation (EU) 745/2017 for Medical Devices
- IEC 82079 compliance
- ISO 3864 and ANSI Z535.6 compliance
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 are convinced it will not come to that.
Product Details
You want to import, trade and/or sell your medical devices 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 an instruction for use template to make it happen.
- Gain confidence when selling your medical device
- Create a compliant manual with this template
- All relevant regulations processed in one template
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.
Compliance
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:
- CE marking compliance
- Compliance with Regulation (EU) 745/2017 for Medical Devices
- IEC 82079 compliance
- ISO 3864 and ANSI Z535.6 compliance
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 are convinced it will not come to that.
With offices in the US, the Netherlands, Germany and China we offer tailored solutions for all complexities our clients encounter. We dedicate our services to improve the safety level for products of our clients and subsequently for a safer world for everyone.