Meet Global Regulation. Increase Patient Safety.
Regulatory changes require medical device manufacturers to modernize the delivery of Instruction for Use (IFU). Manufacturers focused on the consumerization of healthcare create increased patient engagement with a robust and modern eIFU solution powered by the Soom data insight platform.
The Soom eIFU solution allows medical device manufacturers to conform to global laws, including the EU Medical Device Regulation (MDR). Soom integrates with Product Lifecycle Management (PLM) and Content Management Systems (CMS) to ensure version control to end users. Accurate and reliable access to Electronic Instructions for Use allows manufacturers to significantly reduce print and shipping costs. In compliance with regulations, the Soom eIFU solution delivers language specific eIFU through public facing websites and provides call centers to support print IFU fulfillment requests.
The Soom administrative portal allows clients to manage eIFUs and end-user website results. Within the administrative portal authorized users are able to:
- Manage users and roles
- Access reports
- Manage digital content assets (PDF documents, videos, xml etc.)
- Manage digital content asset version control
- Manage document retrieval restrictions
- Submit customer support/feedback to Soom
- Access training and documentation to manage the Soom eIFU system
- View user log reporting (to support Title 21 CFR Part 11)
Client Branded eIFU Public Website
The Soom eIFU solution includes a client branded website for end-users. The eIFU website is designed to provide:
- Global IFU Access
- Intelligent Search Capabilities
- Integrated Search Results
- Flexible Source Format
- Version History
- Universal Web Access
True Patient Engagement — Just a Scan Away
Soom eIFU goes beyond the regulations to create a future-proof eIFU solution. While eIFU regulations are designed to improve patient safety there is risk associated with end-users accessing incorrect information. User interaction is required to identify and request the appropriate eIFU. The Soom mobile scanning application eliminates user error by identifying the correct product information and matching to the appropriate eIFU through scanning. White labeled Soom applications or embedding the Soom Software Development Kit (SDK) into existing manufacturer apps opens the door to true direct to consumer engagement.
- Manage and deliver dynamic eIFU with multi-language support
- Manage data to precise UDI and MDR guidelines
- Improve end user engagement
- Reduce print and shipping costs
- Increase speed to market after revision changes
Interested in delivering eIFU to users from a mobile scan? Contact Soom and speak with the Soom in-house experts.