OpenRegulatory Template

Stakeholder Requirements List

This is a list of your 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 stakeholder requirements 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. Stakeholder Requirements

Your stakeholder requirements should typically take into account:

Stakeholder Requirement ID Stakeholder 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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