Document user expectations providing design compass and regulatory foundation through solution-neutral requirement capture.
User Need ID | Type of User Need | Category | Description |
---|---|---|---|
UN001 | Essential | Safety | The device must not cause skin irritation or allergic reactions during extended wear |
UN002 | Essential | Safety | The device must not pose electrical safety risks to users |
UN003 | Essential | Usability | The device must be intuitive to use without requiring extensive training |
UN004 | Essential | Performance | The device must provide accurate and reliable measurements |
UN005 | Essential | Compatibility | The device must work with common smartphones and operating systems |
UN006 | Product | Usability | The device must be comfortable for all-day wear during office work |
UN007 | Product | Performance | The device must accurately detect stress levels through physiological monitoring |
UN008 | Product | Usability | The mobile app must display stress information in an easily understandable format |
UN009 | Product | Functionality | The device must provide personalized stress management recommendations |
UN010 | Product | Performance | The device must operate for a full workday without charging |
UN011 | Product | Usability | The device must connect to the mobile app automatically without user intervention |
UN012 | Product | Environmental | The device must be water-resistant for handwashing and light rain exposure |
UN013 | Product | Usability | The device must be easy to clean and maintain for hygiene |
UN014 | Product | Performance | The app must provide real-time stress level updates throughout the day |
UN015 | Product | Functionality | The device must track stress patterns over time to identify trends |
UN016 | Product | Privacy | The device must protect user health data and maintain privacy |
UN017 | Product | Usability | The device must be discreet and professional-looking for office environments |
UN018 | Product | Performance | The device must provide consistent measurements across different users |
UN019 | Product | Functionality | The app must allow users to log stress-related events and activities |
UN020 | Product | Usability | The device setup and initial configuration must be simple and quick |
ISO 13485:2016 Section | Document Section |
---|---|
7.2.1 | All user needs |
7.3.3 | All user needs |
IEC 62366-1:2015 Section | Title | Document Section |
---|---|---|
5.2 | Identify user interface characteristics related to safety and potential use errors | UN001-UN005, UN008, UN011, UN013, UN017, UN020 |
5.6 | Establish user interface specification | UN003, UN008, UN011, UN020 |
How do I determine if my user needs are comprehensive enough?
What level of detail should I include in user need descriptions?
How do I handle conflicting user needs from different stakeholder groups?
When should I update user needs during development?
How do I validate that my user needs accurately reflect user expectations?
What's the difference between user needs and system requirements?