Template: User Needs List

Sven Piechottka IEC 62304 Templates Published June 27, 2022

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User Needs List

This is a list of your user needs (also referred to as "stakeholder requirements"). This is what you would
most commonly start with for your requirements mapping: it is the most high-level part of your design
input. Describe the generic requirements your device will need to meet. Only in a next step, these user
needs will be translated into (and linked to) software requirements which will present the technical
specifications of your product.

Of course, you could also use your own tool like Jira or GitHub issues for this. Just ensure that the
content (i.e. the columns shown here) is roughly the same.

Mapping of Standard Requirements to Document Sections

ISO 13485:2016 Section Document Section
7.2.1 (All)
7.3.3 (All)
IEC 62366-1:2015 Section Title Document Section
5.2 Identify user interface characteristics related to safety and potential use errors 1
5.6 Establish user interface specification 1

1. User Needs

Your user needs should typically take into account:

  • Regulatory requirements
  • Use requirements for product functionalities, safety and performance in order to fulfill its intended use.
  • Requirements from risk management: include all hazard-related use scenarios that must be tested during usability tests (note the last column on the right for that).
User Need ID User Group Requirement Description Safety-Critical?
1 User The software returns a score predicting Covid contraction based on (...). Yes
2 User Users can read the instructions for use or contact support in case of questions. Yes
3 Company The software can be integrated with most laboratory systems in the intended use environment. No
4 Regulatory authorities The device is developed in compliance with applicable regulations, norms and standards (e.g. IVDR / MDR, GDPR, HIPAA). No
5 (...) (...) (...)

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Sven Piechottka avatar

Sven Piechottka

With a background in political and administrative sciences, my way into regulatory affairs started from a different angle. I focused on the promises of precision medicine during my final year of studies and first joined IBM to help leverage healthcare innovation projects across Germany.

I then gained most of my regulatory experience while working for Vara (before: Merantix Healthcare), where we built up a quality management system from scratch. For about three years, I coordinated regulatory affairs, led the ISO 13485 certification and CE certification of an AI-based radiology software, and served as data protection officer and quality management officer of the company.