The digital healthcare industry is expanding rapidly. From AI-powered diagnostics and wearable devices to mobile-based wellness apps, a wide range of products are emerging to meet the growing demands of aging populations, chronic diseases, and the normalization of remote care.

As these innovations move into global markets, manufacturers must meet not only performance expectations but also regulatory and user-facing requirements. Among them, the Instructions for Use (IFU) plays a pivotal role — not just for compliance, but for enabling safe and effective product use.

In this article, we explore how digital healthcare companies can build a robust documentation strategy — from regulatory-compliant IFUs to multilingual user guides and digital publishing formats — to succeed on a global stage.

Why Digital Healthcare Products Require More Complex Documentation

Unlike traditional medical devices, digital healthcare products often integrate software, remote connectivity, and personalized configurations. These features introduce more complexity — not only in product development but also in user education and regulatory compliance.

For example, products like cloud-based diagnostic platforms, smartphone-connected glucose monitors, or AI ECG analyzers typically have minimal physical interfaces. This means that user manuals must compensate for what users cannot see or intuitively understand.

Especially for SaMD (Software as a Medical Device), regulatory bodies such as the FDA or EU MDR mandate the inclusion of an Instructions for Use (IFU). These documents must meet strict format, clarity, and content requirements — and not just inform, but protect the end user.

What Types of Manuals Do Digital Healthcare Products Need?

Depending on product functionality and user type, multiple manuals are often required. Here are some common types:

• IFU (Instructions for Use): For patients or medical professionals, ensuring safe and effective use
• Installation Guides: For devices requiring setup or hardware integration
• Administrator Manuals: For hospital IT or cloud platform configuration
• Patient Guides: Simplified, friendly instructions for apps or home-use features
• e-IFU: HTML-based manuals for web/mobile accessibility and easier updates

Each document should be customized by user type and usage context — with structure, tone, and format aligned accordingly.

Regulatory Compliance Isn’t Optional — It Starts with Documentation

In global markets, user manuals aren’t just helpful — they’re legally required. Regulatory bodies set detailed expectations for content structure, language, and usability.

For example:

• FDA (21 CFR Part 801 & Human Factors Guidance): Requires clear labeling, proper device identification, intended use, and human-factor considerations. Especially for patient-facing devices, manuals must account for low mobility, cognitive challenges, and misuse scenarios that could result in treatment failure or harm.
• EU MDR (Annex I – GSPR): Mandates disclosure of residual risks, instructions for trained vs. untrained users, and conditions under which the device may malfunction. For example, labeling must clearly indicate if a device is unsuitable for pacemaker users or pregnant individuals.
• Global standards like ISO 20417, IEC 82079-1, ISO 15223-1, and IEC 62366[WU1] [WU2] [WU3] [WU4]  provide further requirements for symbols, structure, and usability.

Failure to meet these standards can delay market entry, cause rejection during review, or even result in product recalls.

Common Documentation Challenges in Real Projects — and How to Avoid Them

Even when companies understand the regulations, documentation often falls short due to practical issues in real-world development. Here are five common pitfalls and how to address them:

• Manual structure doesn’t match the user’s workflow
  Manuals that mirror internal features rather than actual usage confuse the end user.
  → Use task-based scenarios to structure the flow logically.
• UI labels and manual terms don’t match
  E.g., screen says “Begin Measurement” while the manual says “Start Scan.”
  → Implement a centralized terminology system and enforce consistency.
• Regulatory language is too technical for the user
  Verbatim regulatory text may comply, but overwhelms or confuses patients.
  → Apply Plain Language principles while maintaining compliance.
• Mixing instructions for multiple user types
  Combining patient and medical professional instructions causes misunderstanding.
  → Segment manuals by user type or role wherever possible.
• Manuals are in PDF only, and not mobile-friendly
  Apps or digital products often need responsive HTML-based manuals to support e-IFU and multi-device access.

Great documentation requires both regulatory awareness and human-centered thinking — not just compliance, but communication.

Partnering for Success: Hansem Global

At Hansem Global, we understand that documentation is not just about writing — it’s about enabling safe and confident use of your product across borders.

With decades of experience in technical communication and localization for industries like IT, medical devices, and digital platforms, we offer:

• Documentation planning tailored to international standards and user needs
• UI-integrated terminology management
• e-IFU design optimized for web and mobile
• Multilingual content production in 50+ languages

From the first line of your user guide to the final translated paragraph in a new market, Hansem Global helps you bridge the gap between product and user — globally.