Build a compliant eIFU website.Without guessing.
A practical whitepaper on the software requirements for a compliant eIFU platform
Covering Medical Devices and In Vitro Diagnostics under EU MDR, IVDR, and global expectations.
- Share internally with QA, RA, and IT
- Use as a checklist for vendors or internal builds
- Refer to during audits and inspections
Regulatory deadlines are already in effect. Delays in eIFU decisions increase submission risk and audit exposure.
Download your free copy
Fill in your details to receive the whitepaper instantly.
Trusted by leading medical device manufacturers
Inside this whitepaper, you'll discover:
Regulatory expectations for eIFU websites
What EU MDR, IVDR, FDA, and guidance documents actually require from your platform
Core software and security requirements
Data protection, availability, audit trails, version control, access management
How SDLC applies to eIFU systems
From planning and design to validation, deployment, and maintenance
What auditors look for in practice
Validation evidence, traceability, and system robustness
How to avoid common compliance pitfalls
And why many in-house or "simple" web solutions fail audits
This is not theory. It is an execution guide.
This guide is relevant if you are
- Medical Device manufacturers
- IVD manufacturers
- Quality & Regulatory Affairs professionals
- IT and digital teams supporting regulated software
- Manufacturers considering in-house eIFU development
Written by regulatory experts, not marketers
This guide is based on:
- Real regulatory requirements
- SDLC principles aligned with IEC 62304
- Practical experience supporting audits and inspections
- Years of operating validated eIFU platforms
No generic "digital transformation" talk. Just what works under scrutiny.
Stop assuming your eIFU website is compliant
Download the whitepaper and get clarity on what regulators actually expect.