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Customer Success Stories

Switch from paper to electronic Instructions for Use with Matrix eIFU

Guarantee real-time access to the latest documentation for healthcare professionals and patients, with full audit readiness. Our cloud-based solution Matrix eIFU (previously Dokspot) offers easy online access to your medical device instructions for use (IFUs) and other essential documentation.

Why use Matrix eIFU?

3clicks access to your documentation

1day to have your eIFU website

24/7availability

100%compliant

Core Matrix eIFU features

With Matrix eIFU, build tailored Electronic Instructions for Use for your medical devices or drug in white label for a seamless experience.

ComplianceMeet eIFU regulatory requirements from global markets with a solution that adapts to changes according to growing requirements.

DocumentationDon't reinvent the wheel. We offer templates for all the eIFU quality assurance processes including software and system validation reports.

SecurityWe focus on eIFU and building the best and most robust technology stack to deliver a secure and reliable service to our customers.

ModulesAudit logs, change records, approval process, paper orders, version management, website translations, geo-fencing. We have you covered.

SupportWith an average response time of 1 hour, our dedicated support team is committed to assisting you every step of the way.

OnboardingSelect a partner that guides you throughout your eIFU journey providing you with training, advice, and experience.

Hear from our customers

"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 Matrix eIFU. 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 No more printing orders, shipping of paper to the various warehouses, inventory of paper IFUs and replacement of outdated IFU versions.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

Trusted by 300+ SxMD & Medical Device Companies

FAQ

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.

How do eIFUs impact 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.

How do eIFUs impact 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.

Matrix eIFU Terms & Conditions