Description:

Capture medical device user requirements in a single, traceable form to guide design and validation from project start.
• Define Scope and Project Name to set boundaries for development.
• Record project identification and the DHF number for design control traceability.
• Document the Device Description, constraints, and operating context.
• Specify proposed intended use, intended users, and patient profile.
• Identify target markets of interest to map applicable legal constraints (e.g., MDR GSPR).
• Translate needs into measurable User Requirements (UR) with clear acceptance criteria and Source of AC.
• Assign a planned Design Validation Method for each UR to build the traceability matrix.

Your needs:

• medical device user requirements in alignment with ISO 13485 requirements and MDR decision-making
• use an easy to use template
• reduce rework and audit risk with an unambiguous and systematic approach to define the user requirements.

Use this form at project kick-off (and update it as the concept matures) to ensure user needs for performance, safety, usability, and overall benefit are captured before design inputs are finalized.

In practice, acceptance criteria are measurable thresholds that prove a requirement is met, and the Design Validation Method defines how you will demonstrate it with users and real-use conditions. Key requirements include:
• Document applicable legal framework expectations (including MDR GSPR where relevant).
• Define user training/competency needs (IFU, workflow, decision support).
• Set functional performance needs (precision, response time, operating modes).
• Capture Labeling & Packaging requirements (labels, IFU, shipping).
• Address Software & Cybersecurity needs (access control, updates, backups).
• Define Usability and Safety needs to mitigate foreseeable misuse.

We support you within Lexqara with UR workshops, DHF-ready wording, and alignment to risk management, design support, and audit readiness. Use our Resource Center and our Design Control service for Start-up Companies, and keep the legal baseline handy via EU MDR (Regulation (EU) 2017/745). Download the template or request a short gap assessment.