dokspot is the IFU management solution compliant with global eIFU regulations. Designed by regulatory experts and software engineers, the product provides medical device manufacturers with a controlled and convenient solution to communicating their IFU online.
Get Starteddokspot was developed by regulatory experts and software engineers to meet the requirements of global eIFU regulations. The product provides off-the-shelf eIFU compliance to device manufacturers.
Commission Regulation (EU) No 2017/745 (MDR) Article 23.1
Commission Regulation (EU) No 207/2012
Section 206 Medical Device User Fee and Modernization Act
CFR Title 21 Part 11
Further international eIFU regulations have been published by:
Manage all your eIFU with dokspot. Provide them to your customers with a direct link to your products under your corporate brand.
See How it Works
dokspot is convenient. The product enables you to introduce eIFU to your organisation, your products and your customers without investment of your resources into development and maintenance of software and hardware.
See How it Works
Transitioning to eIFU will be a winner for your organisation and your budget. eIFU can free up packaging and inventory capacity. Obsolete inventory will no longer burden for your budget. And quality processes like shelf-life testing will be less complex with eIFU.
Learn MorePatient safety is the first priority. Yet, it is difficult to demonstrate that healthcare providers have read device instructions. 95% of health care professionals (HCP) admit that they hardly ever read instructions. dokspot QA Certificates provide you and your customers with a QA mechanisms to ensure HCP’s read your instructions.
See What's Included
Looking to improve your time to market? Traditionally organisations are forced to have multiple SKUs for different markets or face bottlenecks while waiting for all translations. dokspot allows you to launch by-market while managing a single SKU per product.
Learn MoreOver 5 million trees are cut down annually in order to produce paper IFUs. Every manufacturer that transitions to e-IFU reduces that number. Our environmental report presents you with the real impact of paper IFUs.
The ReportMDR Compliant Website
eIFU Compliant Service
FDA Compliant Service
Product Management
Document Management
Notification Management
Approval Workflows
Custom Branding
Order Management
Custom Domains
