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.
This whitepaper gives you a practical overview to help you implement eIFU correctly, efficiently, and with confidence.
eIFU is not "just a website"
An eIFU platform is regulated software. That means:
It must meet strict regulatory and cybersecurity requirements
It must follow a validated Software Development Life Cycle (SDLC)
You must be able to prove compliance during audits
Downtime, security gaps, or missing traceability can trigger findings
Many manufacturers underestimate this. Auditors do not.
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
If you are responsible for compliance, this is required reading.
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.
Whitepaper (PDF)
"Software Requirements for a Compliant eIFU Website Development"
A structured, audit-ready reference you can:
- Share internally with QA, RA, and IT
- Use as a checklist for vendors or internal builds
- Refer to during audits and inspections
Stop assuming your eIFU website is compliant
Download the whitepaper and get clarity on what regulators actually expect.
Download your free copy
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