redwitch

📄 Red Witch – Post-Market Surveillance (PMS) Log

Purpose: The Post-Market Surveillance (PMS) log tracks external reports, user feedback, and research findings relevant to Red Witch. PMS ensures continuous monitoring of safety, privacy, usability, and regulatory compliance, feeding improvements into the SRS, RMF, and QMS.

Procedure Reference: RW-QMS-005 – Post-Market Surveillance Procedure

Last Updated: 2025-10-02 Owner: QA/RA Manager

1. PMS Log Table

PMS ID	Source	Type	Summary	Related RMF / SRS	Action / Status	Review Date	Owner	Link
PMS-001	Cambridge Report – Minderoo Centre, 2025	External Report / Risk	Commercial exploitation of menstrual data by profit-driven cycle tracking apps; privacy, safety, and reproductive rights risks.	R-Ext-001, R-Ext-002, R-Ext-003	Include in RMF and SRS as design input; monitor for regulatory updates	2025-10-30	QA/RA	Link to Design Input
PMS-002	PMC Review of 49 Studies, 2023	External Report / Design Input	Language barriers, technology access limitations, digital literacy challenges, and cultural sensitivity affecting global adoption of menstrual tracking apps.	DI-001 to DI-006	Include in SRS and RMF; monitor user adoption metrics	2025-10-30	Product Team	Link to Design Input
PMS-003	Women’s Health – Best Period Tracker Apps, 2023	Market Report	Comparison of 11 leading apps; highlights FDA clearance gaps, user frustration with monetization, privacy concerns, and new usability features.	R-Ext-007, R-Ext-008, R-Ext-009	Add warnings for off-label use; monitor reviews for monetization/privacy; evaluate future roadmap features	2025-10-30	QA/RA + Product	Existing Solutions & Market Comparison
PMS-004	Peer-Reviewed Review of Menstrual Tracking Apps (PMC, 2023)	External Report / Scientific Literature	Academic evaluation of app quality; found limited scientific validation, evidence gaps, and risks of off-label contraceptive use.	R-Ext-007, R-Ext-010	Update SRS for evidence transparency; disclaimers on accuracy and intended use	2025-10-30	QA/RA	PMC Article

2. PMS Workflow

Identification
- Sources: Academic research, media reports, regulatory alerts, user feedback, app store reviews.
- Assign a unique PMS ID to each item.
Documentation
- Record source, type, summary, potential risk or design input, linked RMF/SRS references, and owner.
Evaluation
- Determine if the item represents a risk, a new design input, or both.
- Assign to appropriate team (QA/RA, Product, Development).
Action / Mitigation
- Update RMF, SRS, or QMS procedures as necessary.
- Monitor and track outcomes (e.g., app updates, user education materials).
Review & Reporting
- Conduct PMS reviews quarterly or after major findings.
- Record updates, new actions, and status in this log.

3. Notes

All PMS items must be version-controlled in accordance with RW-QMS-002 – Document Control Procedure.
External reports should not be copied in full; provide a summary and a link to the source.
PMS entries can be linked directly to Design Input Wiki pages for traceability.

4. Future Expansion

Add user complaints as they are received.
Include regulatory alerts or safety notices relevant to data privacy, medical device classification, or digital health regulations.
Track post-release app metrics, such as adoption rates, crashes, or reported privacy issues.

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