Communicate your Instruction for Use electronically (eIFU), compliant with EU and FDA regulations. Free your organisation, products and customers from the complexity caused by printed IFU.
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The dokspot service was developed using the FDA and European Union regulations as its foundation, to make it a ready to use MDR website and eIFU service for Medical Device Manufacturers.
Commission Regulation (EU) No 2017/745 (MDR)
Commission Regulation (EU) No 207/2012
Section 206 Medical Device User Fee and Modernization Act
CFR Title 21 Part 11
Other compliant regulatory authorities include:
Organise all your Instructions for Use on a single platform. Publish them in a controlled environment linked to your products. Securely share them with your customers under your corporate brand.
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We provide a reliable eIFU Service enabling you to introduce eIFU to your organisation, your products and your customers in compliance with medical device regulations. Without investment and diversion of your resources for development and maintenance of software and hardware.
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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.
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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
