PulseNest Wearable SpO2/HR Patch

ISO/IEC/IEEE 15288 · 21 CFR 820.30. Continuous non-invasive SpO2 and heart-rate monitoring via an adhesive wearable patch for ambulatory adults.

Requirements frozen

79%

19 of 24 approved or baselined

V&V trace

63%

3 cases passed · 3 executed

Open risks

11

7 high residual · 2 untreated

Next gate

MS-DF

Design freeze · Sep 18, 2026

Technical process

V-model

Left decomposes · right verifies

Stakeholder needs

6 of 6 frozen

Validation

0 of 2 protocols complete

System requirements

9 of 11 frozen · 6 with V&V

System verification

2 of 8 protocols active

Architecture

13 elements · 6 ICDs

Integration

3 of 10 cases executed

Implementation · detailed design

12 software · 6 hardware · 18 traced

Technical baseline health for PN-WSP in Detailed design · CDR.

Requirements frozen79%

Allocated to architecture100%

Parent trace (non-STK)100%

Requirements with V&V63%

Gaps the CDR still has to close.

Viewing PN-WSP·this product only·pl-ris.meridian.json·Autosave in the local workspace·Acting asMasterDetailed design · CDR