Visu eIFU

Visu eIFU is an electronic Instructions for Use (eIFU) platform developed by DDi, designed for medical device and in vitro diagnostic (IVD) manufacturers. It provides an end-to-end solution for publishing, managing, and distributing digital IFUs in compliance with global regulatory requirements, including EU MDR, FDA 21 CFR Part 11, and regulations in Canada, Brazil, Australia, and Saudi Arabia. The platform is ISO 13485 certified for quality management and hosted in ISO 27001 certified data centers located in the USA and Germany.

Visu eIFU is intended for medical device manufacturers seeking to replace or supplement paper-based labeling with a compliant, configurable digital portal. The platform has over ten years of experience in the field and is trusted by notified bodies and leading MedTech companies.

Global Regulatory Compliance

• Covers EU MDR, FDA, Canada, Brazil, Australia, and Saudi Arabia regulatory requirements
• Compliant with FDA 21 CFR Part 11 for electronic records and signatures
• Tracks country-specific regulatory changes and informs manufacturers of updates
• Full GDPR compliance with all audit-ready documents provided
• Data centers certified to ISO 27001 for information security
• Supports relevant EU regulations including Commission Implementing Regulation (EU) 2021/2226, Regulation (EU) 2017/745 (MDR), Regulation (EU) 2017/746 (IVDR), and Commission Regulation (EU) No 207/2012

eIFU Portal Configuration and Usability

• Available as an off-the-shelf solution or as a custom-configured portal
• Highly configurable interface tailored to a manufacturer's device portfolio
• Smart search functionality for end users
• Personal training provided on use of the Visu eIFU platform
• Expert regulatory support included
• Designed for straightforward implementation without significant technical overhead

Document and Access Management

• Role-based access control for manufacturer administrators
• Built-in workflow management and electronic document management system (EDMS) functionality
• Full audit trail and backend reporting available for self-service use
• Ability to control content visibility separately for healthcare professionals and patients
• Content management by country and language
• Subscription and notification features for end users when documents are updated
• Enterprise edition supports PLM/EDMS integration, advanced workflows, and custom branding

Security and Audit Readiness

• Hosted in ISO 27001 certified data centers in the USA and Germany
• GDPR compliant data handling
• Comprehensive backend analytics and role-based access control
• Full audit trails for traceability
• All audit-ready documentation provided to support regulatory inspections
• 100% audit-ready status maintained

Print Services

• Integrated print request management service compliant with ISO 20000
• Guaranteed 7-day turnaround on print requests in accordance with EU regulatory requirements

Supported Regulatory Frameworks and Standards

• EU: MDR (2017/745), IVDR (2017/746), MDD-era Regulation (EU) No 207/2012, MEDDEV 2.14/3 rev.1, GDPR (2016/679)
• USA: FD&C Act, FDA 21 CFR Part 11, MDUFMA Section 206, FDA guidance documents on electronic labeling
• Canada: Health Canada guidance on labeling of medical devices (Notice 10-123767-875)
• Brazil: Normative Instruction IN No. 4 (June 2012)
• Saudi Arabia: SFDA/MDS Guidance MDS-G41 on eIFU requirements
• Australia: TGA guidance on eIFU for professional users (v1.0, August 2018)
• International standards: IEC 62304 (medical device software lifecycle), ISO 13485 (quality management), ISO 14971 (risk management)

Visu eIFU is part of a broader suite of regulatory solutions offered by DDi, which also includes UDI compliance tools, Regulatory Information Management (RIM) software, and EUDAMED support. The platform integrates with enterprise systems such as PLM and EDMS in its enterprise edition, and is developed in accordance with IEC 62304 software lifecycle processes.