dokspot - Electronic Instructions for Use (eIFU)

For Medical Device and In vitro Diagnostic Device manufacturers

Enhance Customer Experience with the dokspot eIFU Service

Take control of your customer's experience with our cloud-based eIFU software. Our innovative solution allows you to provide 3 click to your medical device instructions for use (IFUs) and other essential documentation directly through your branded website,

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Fulfill Global Medical Device Regulations with the dokspot eIFU Solution integrated into your IFU system

The dokspot eIFU software provides all functionalities for compliance with Reg (EU) 2021/2226. When you onboard, we will guide you through the transition process and provide the necessary Quality Assurance (QA) documentation and templates that are required for the completion of your QA documentation.

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Improve your bottom line by moving to an electronic IFU process

Experience the benefits of a proven and validated eIFU system. When using the dokspot eIFU service, we manage the software and infrastructure. This allows you and your staff to dedicate time and resources to value-adding business tasks knowing that your eIFU service is being monitored, maintained, and improved upon.

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The eIFU solution supporting your digitalization and sustainability strategy

Meet or exceed your corporate social responsibility (CSR) goals by going paperless; avoiding waste and supporting 

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eIFU Explained

What are eIFU?

An eIFU is the electronic version of a paper IFU provided with the device. It is an integral part of the medical or IVD device. A well implemented eIFU system can help maintain or improve patient safety while reducing production costs and environmental burden.

What are the

eIFU Regulations and Guidelines?

The provision of instructions for use of medical and IVD devices in electronic format (eIFU) is regulated. For Europe regulation (EU) 2021/2226 specifies the requirements for medical device eIFU. eIFU regulations are also released in many other countries including  Australia, Brazil, Canada, Turkey, and the USA. In addition to regulations, industry quality standards, and processes are essential for a compliant eIFU system.

What are the

eIFU Quality Assurance (QA) Requirements?

An eIFU System is a computer system requiring computer system validation (CSV). The quality assurance requirements of the eIFU System concern software, medical device data, and eIFU processes. The specifications of these three components from the basis for CSV. The QA documentation may be reviewed during audits.

Impact Your Bottom Line

Driving Efficiency, Safety, and Cost Savings

Designing, developing, validating, and maintaining an eIFU software in today’s fast paced digital world is time consuming, costly and difficult to manage given the daily recurring tasks. Using an off-the shelf eIFU service makes cost transparent and planable.

User Experience

Unique eIFU 
Customer Experience

An eIFU website is intended for users of medical device. Clearity, intuitive operation, and quick eIFU access are key requirements for customer satisfaction. Complex navigation combined with repeated confirmation requirements are contra productive.

Learn more about eIFU System implementation

We can assess your situation and provide an high level implementation plan considering all aspects listed above.

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The Benefits of Our eIFU Solution
Streamlined Processes, Compliance, and Customer Satisfaction

The dokspot eIFU Service

dokspot is a white label eIFU service. For this reason, the statements below do not mention names. Nevertheless, the sources are open to share their experiences. Please contact us if you would like to talk with a dokspot customer.

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What our clients say

To change all the IFU related processes, from a paper version IFU to an eIFU system takes some effort and is a change management process on several levels. In our experience: The process has been perfectly guided and supported by dokspot. The elimination of the paper IFU was a relief. No more printing orders, shipping of paper to the various warehouses, inventory of paper IFUs and replacement of outdated IFU versions. There is a significant financial benefit for our organization and the move was worth the investment.

Regulatory Affairs Manager

Leading orthopedic devices manufacturer in Switzerland

Sustainability is an issue on our side and appreciated by our customers.
Reducing paper does not only have economic potential but does also meet the sustainability goals of our company. It is one step to reach CO2 neutral medical device production. Customer feedback for the eIFU was very positive. Hospitals today do also have a waste management issue and the reduction of any paper waste is very welcome.

Regulatory Affairs Manager

Leading orthopedic devices manufacturer in Switzerland

dokspot did help us to set up the eIFU System for our product portfolio in an very short time and supported us with all the QA documentation to meet the MDR requirements. The eIFU system was with no delay accepted by our notified body and internal and external audits did accept all the QA documentation provided.

Director of Regulatory Affairs

Medical device manufacturer California, United States