Areneco’s turnkey solution provides all the elements required for Medical Device Manufacturers to make the transition to eIFUs. It includes the necessary QA/RA competencies, project management experience and the software required to complete this successfully.
The software itself is called STRATUS and is designed to be fully customisable to ensure the wide ranging and varying requirements from company to company are easily fulfilled.
The solution brings the end user into the supply chain and provides them with not only an electronic version of the IFU, but also added value services such as customer support, additional documentation, troubleshooting, maintenance documentation and all other product related information from multiple manufacturers in one central location.
This will reduce cost, risk and environmental impact while improving supply chain efficiency.
Software functionality includes:
- Web based portal for MDC Users
- End to end document control
- Centrally managed end user web access to eIFUs via URL and QR Codes
- Customer support portal via online chat or email (Areneco - MDC - End User)
- ISO certification and compliant with EU & US regulations
- Independently validated, assisting in a more efficient device approval process
Consultancy Services include:
- Mapping as is and completing a gap analysis and change impact analysis
- Calculating Cost to Convert, ROI and making business case for changeover
- QA/RA evaluation – as is/proposed
- Risk Assessments
- Project Management
- Process re-engineering
- Lean principles
- Process changeover in live environment
Get In Touch
If you would like to discuss how Areneco can help you deliver your IFUs via the web or to schedule a demo, please get in touch with us and we will be more than happy to help in whatever way we can.