eIFU - Electronic Platform for Instructions for Use
Web-based ready-to-use platform, validated and certified according to all EU, MDR and FDA regulations. Choose your own branding, version and upload documents in various formats as well as video files.
Our eIFU platform provides you with a ready-to-use, web-based solution for providing electronic instructions for use. The platform is specifically tailored to the requirements of the medical technology industry and helps you to overcome regulatory hurdles efficiently.
Digital Compliance & Security
- Regulatory Compliance: Fully validated and certified according to all current EU (MDR) and FDA regulations.
- Highest Quality Standards: Certified according to ISO 13485 and computer system validated (CSV) according to GAMP 5 2nd Edition.
- Individual Branding: The platform can be flexibly adapted to your own branding (Corporate Identity).
- Seamless Documentation: Legally compliant versioning and easy uploading of documents in various formats as well as instructional videos.
Complementary Medical Print Services
In addition to the digital solution, we support you as experts in Medical Print for the physical implementation of your documentation. As a Swiss Medtech member, we guarantee the highest quality through validated production processes:
- Specialized Package Inserts: Production of micro-folded leaflets and multi-page booklets on certified pharmaceutical paper (40–60g/m²).
- Labeling & Artwork Management: Professional consulting on the design and optimal format of your IFUs.
- Versatile Printing Processes: Precise implementation in web and sheet-fed offset as well as digital printing for flexible print runs.
Visit us at our booth and request your personal sample box with various processing examples!
