Matrix eIFU software includes the software QA documentation required for quality audits.

Developed and managed  under a ISO 9001 certified quality management system, your eIFU website is controlled for availability 24/7.

Your data is hosted in high quality, ISO 27001 certified data centers. As a Matrix eIFU customer, you save time and resources through templates for your QA documentation.

We provide the required regulatory background and documentation to you.

Not only includes our eIFU Service the features for regulatory compliance, we also guide you in the eIFU transition to save your time and resources.

The Matrix eIFU Service supports your product management in the execution of commercial strategies.

As a product manager you release IFUs and other product use documents in the required languages exactly at the planned time.

Our eIFU Solution will free up supply chain resources. Matrix eIFU provides blueprints for eIFU based supply chain processes which ensure the compliance of your devices. Requests for IFU in paper format are managed by Matrix One with the time spans required by regulations.

Matrix eIFU also reduces complexity and risks in the planning and production process. Our eIFU solution and guidance allows you to plan and implement eIFU packaging and labeling today and get ready for new packaging requirements like implant cards.

The Matrix eIFU solution requires no upfront investment and software update and maintenance cost are included in the subscription fee.

The reduction of product standard cost through removing the paper IFU is realized much quicker. Through Matrix eIFU guidance and support the cost for resources is reduced.

As a marketing professional your goal is to promote your company and brand.

Matrix eIFU is a white label product that stays completely in the background, so that your customers only ‘see’ you and get a positive brand recognition by an easy and clear eIFU website that delivers the required result in just 3 clicks.

Matrix eIFU supports your digitalization and sustainability strategy.

Using Matrix eIFU instead of paper-based IFU will help you meet or exceed your corporate social responsibility (CSR) goals by reducing paper consumption and CO2 emissions, and avoiding waste.

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.

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.

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.

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.

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.