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, ifu.yourcompanywebsite.com.
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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.
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.
Meet or exceed your corporate social responsibility (CSR) goals by going paperless; avoiding waste and supporting
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.
We can assess your situation and provide an high level implementation plan considering all aspects listed above.
dokspot 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 dokspot customer, you save time and resources through dokspot templates for your QA documentation.
The dokspot 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.
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.
Our eIFU Solution will free up supply chain resources. dokspot provides blueprints for eIFU based supply chain processes which ensure the compliance of your devices. Requests for IFU in paper format are managed by dokspot with the time spans required by regulations.
As a marketing professional your goal is to promote your company and brand. dokspot 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.
Reduce complexity and risks in the planning and production process. The dokspot 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 dokspot 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 dokspot guidance and support the cost for resources is reduced.
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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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.
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.
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.
dokspot GmbH
Freudenbergstrasse 101
8044 Zurich
Switzerland