Verify design completeness and readiness for verification through systematic review criteria and evaluation.
Checklist Items | Yes/No | Justification if No |
---|---|---|
Each user need has an identifiable number for traceability. | Yes | User needs UN-001 through UN-015 all assigned unique identifiers |
The user needs address all relevant stakeholder requirements. | Yes | Requirements from cardiologists, patients, and IT administrators captured |
The user needs take into consideration all relevant aspects of intended use. | Yes | Includes home monitoring, clinical review, and emergency detection scenarios |
The user needs include all necessary organizational, technical, or other requirements. | Yes | HIPAA compliance, FDA cybersecurity, and clinical workflow requirements included |
The user needs are not ambiguous, self-contradicting or conflicting with each other. | Yes | Requirements review identified and resolved three conflicts in version 2.0 |
Design inputs align with user needs, intended use, and regulatory requirements. | Yes | Traceability matrix demonstrates complete alignment with 21 CFR 820.30 |
Product design can be manufactured, assembled, and tested. | Yes | Manufacturing partner confirmed feasibility and provided cost estimates |
Risk control measures have been incorporated into the design, if applicable. | Yes | Implemented encryption, signal validation algorithms, and fail-safe mechanisms |
Criteria | Yes/No | Comments |
---|---|---|
The software architecture implements all system and software requirements. | Yes | Architecture review confirmed coverage of SRS-001 through SRS-087 |
All software systems are listed and their respective safety class has been determined. | Yes | Mobile app: Class B, Cloud backend: Class A, Sensor firmware: Class B |
All software items are listed and described, including interfaces. | Yes | 12 software items documented with API specifications and data schemas |
The software architecture supports interfaces between software items and between software items and hardware. | Yes | Bluetooth LE, HTTPS REST APIs, and USB interfaces fully specified |
The architecture supports proper operation of any SOUP items, as needed. | Yes | React Native, AWS services, and encryption libraries properly integrated |
The software architecture can be implemented with resources provided by the manufacturer. | Yes | Development team skills assessed, AWS infrastructure capacity confirmed |
Checklist Items | Yes/No | Justification if No |
---|---|---|
Design and assembly schematics of the product are complete and meet requirements. | Yes | Electrical schematics, PCB layout, and enclosure drawings approved by engineering |
Material selection meets biocompatibility and durability needs. | Yes | Medical-grade silicone tested per ISO 10993-5, ABS plastic for 5-year lifecycle |
Physical, environmental, performance, and safety factors have been considered in the design. | Yes | IP65 rating for water resistance, drop testing specifications, EMC compliance plan |
Design follows Electromagnetic Compatibility (EMC), safety, and environmental compliance, if applicable. | Yes | Pre-compliance testing completed, formal EMC testing scheduled before release |
Design of packaging and shelf-life is compliant with product and regulatory requirements. | Yes | 24-month shelf life validated, packaging includes all required labeling elements |
How can user needs be documented to ensure they are comprehensive for design review?
How should system requirements be structured to pass design review?
What should be done if the design review identifies missing or incomplete requirements?
How should software architecture be documented to demonstrate regulatory compliance during design review?
What constitutes adequate risk control measure integration in design?
How should design review checklist findings be documented and managed?