PSP Risk Register 2026 — HigginsReports DEMO

🗓️ 90-Day Risk Burndown Plan — PSP Methodology · Demo Data

⚠️ All risk entries, owners, budgets, and scores referenced below are entirely fictional demo data. The 90-day framework is based on real PMI Disciplined Agile, ISO 14971 §7 risk control, and 21 CFR 820 CAPA best practices.

2,870

Starting RPN (Day 0)

1,610

Target — Day 30

860

Target — Day 60

574

Target — Day 90 (80% ↓)

RPN Points/Day Required

$165K

Total 90-Day Budget (Demo)

90-Day RPN Burndown Trajectory — Target vs Planned (Demo)

Weekly RPN Reduction Targets

Budget Allocation by Phase (Demo)

🔴 PHASE 1 — Days 1–30

Emergency Response: Critical Risk Elimination

−1,260 RPN

2,870 → 1,610 · Budget: $85K Demo

📅 Week 1 (Days 1–7)

Form emergency teams, PRN-3 root cause analysis, AFM surface study, FDA Q-Sub request, CAPA linkage for all RPN >350. Gate: Team Formed

📅 Week 2 (Days 8–14)

PRN-3 hydrophilic coating trials, SRN-1 nozzle prototype, PRN-1 folding analysis, ISO 14971 §7.3 controls documented. Gate: Solutions Viable

📅 Week 3 (Days 15–21)

Material reformulation testing, fluid dynamics simulation, PRN-5 design sprint, PMS protocol drafted. Gate: Testing Active

📅 Gate 1 — Day 30

PRN-3: 490→200, SRN-1: 350→140, CAPA 100% linked. FDA Q-Sub scheduled. ✅ Executive Sign-Off

🟠 PHASE 2 — Days 31–60

Systematic Reduction: Moderate Risk Resolution

−750 RPN

1,610 → 860 · Budget: $55K Demo

📅 Week 5–6 (Days 31–44)

PRN-3 100-sample validation, shelf-life parallel testing, PRN-5 design validation, OTF MTF baseline initiated. Gate: Validation Active

📅 Week 7–8 (Days 45–60)

PRN-6 aging results, benefit-risk analysis, FDA Q-Sub Meeting #1, CAPA closure ≥80%. Gate: FDA Feedback

📅 Gate 2 — Day 60

Phase 1 risks ≤50% original RPN, ISO 14971 §9 Risk Mgmt Report draft complete. ✅ Regulatory Sign-Off

🟡 PHASE 3 — Days 61–80

Optimization: Slight Risk Closure

−286 RPN

860 → 574 · Budget: $18K Demo

📅 Weeks 9–11 (Days 61–80)

Remaining slight risks resolved, DHF 95% complete, traceability matrix finalized, ISO 14971 §8 overall residual risk evaluated. Gate: Regulatory Package Ready

🟢 PHASE 4 — Days 81–90

Verification & Lock: 80% Burndown Confirmed

LOCK

Maintain ≤574 · Budget: $7K Demo

📅 Gate 3 — Day 90

Final RPN ≤574, ISO 14971 compliance ≥85%, Risk Management File locked, PMA roadmap Q3 2027 activated. ✅ 90-Day Complete

90-Day Milestone Tracker

Day 1 — Emergency Team Formation

Alpha (Materials), Beta (Design), Gamma (Validation) teams formed. CAPA system activated for all RPN >350 risks. Risk Management Plan per ISO 14971 §4.4 initiated.

Day 7 — Root Cause Analysis Complete

PRN-3 surface polarization root cause confirmed. SRN-1 nozzle geometry analysis complete. FDA Q-Sub meeting request filed. CAPA records created for all critical risks.

D14

Day 14 — Solutions Initiated

Hydrophilic coating trials active. Nozzle redesign prototypes in testing. Folding mechanism analysis underway. ISO 14971 §7 risk control measures documented.

Day 30 — GATE 1: Technical Feasibility Confirmed

PRN-3 RPN reduced from 490 to ≤200. SRN-1 RPN reduced from 350 to ≤140. CAPA system 100% linked for critical risks. FDA Q-Sub meeting scheduled. Executive sign-off required.

D45

Day 45 — FDA Q-Sub Meeting #1

PMA pathway confirmed. Clinical protocol feedback received. Biocompatibility testing plan aligned with ISO 10993. Q-Sub #2 scheduled for Q2 2026.

Day 60 — GATE 2: Solution Effectiveness Validated

All Phase 1 risks validated at ≤50% original RPN. CAPA closure rate ≥80%. ISO 14971 §9 Risk Management Report draft complete. Regulatory sign-off required.

D80

Day 80 — Regulatory Package Ready

DHF completeness at 95%. Traceability matrix 100% complete. ISO 14971 §8 Overall Residual Risk evaluated. PMS plan finalized. FDA Q-Sub #2 scheduled.

Day 90 — GATE 3: 80% RPN Burndown Confirmed ✅

Final RPN ≤574 confirmed. ISO 14971 compliance ≥85%. Risk Management File locked. PMA submission roadmap for Q3 2027 activated.

90-Day RACI Matrix — Fictional Demo Contacts

Activity	Demo Contact A (Materials)	Demo Contact B (Design)	Demo Contact C (Validation)	Demo Contact D (PM)	Regulatory Affairs
PRN-3 Surface Treatment	R	C	I	I	I
SRN-1 Nozzle Redesign	C	R	I	I	I
PrRN-2 Shelf-life Testing	I	I	R	A	C
CAPA System Linkage	C	C	C	R	A
FDA Q-Sub Preparation	C	C	C	C	R
Risk Management Report (§9)	C	C	R	A	C
Gate Reviews (1, 2, 3)	C	C	C	R	A

R = Responsible · A = Accountable · C = Consulted · I = Informed · All names fictional demo contacts only.

Critical Risk Mitigation — Fictional Demo Data

⚠️ All mitigation plans, budgets, timelines, and personnel are entirely fictional. Strategies follow real ISO 14971 §7 risk control principles.

Mitigation Investment by Risk — Demo ($)

RPN Reduction Post-Mitigation — Demo

PRN-3 — Fictional: Adhesion During Unfolding (RPN: 490) — PRIORITY 1

Phase	Timeline	Actions (Fictional)	Budget (Demo)	Success %
Phase 1: Investigation	Wk 1–2	AFM surface analysis, polarization testing	$50,000	—
Phase 2A: Hydrophilic Coating	Wk 3–6	Hydrophilic coating application	$25,000	85%
Phase 2B: Material Reformulation	Wk 3–8	Material reformulation study	$75,000	70%
Phase 3: Validation	Wk 7–12	100-sample bench study, advisory review	Included	95%

SRN-1 — Fictional: Nozzle Design & Surface (RPN: 350) — PRIORITY 2

Action	Timeline	Description (Fictional)	Budget (Demo)
Root Cause Analysis	Jan 20–31	Nozzle surface interaction modeling, fluid dynamics simulation	$30,000
Geometry Optimization	Feb 1–28	Reduced contact area, controlled flow paths, enhanced surface finish	Included
Combined Elimination	Mar 31	Target zero adhesion at nozzle interface — 840 combined RPN reduction	—

FDA Regulatory Strategy — Demo Data · Real Standard Requirements

⚠️ All compliance scores and risk entries are fictional demo data. Regulatory requirements cited are real FDA and ISO standards.

45%

Demo Compliance Score

95%

Target Score

PMA

Recommended Pathway

Q4 2027

Demo Approval Target

Regulatory Risk Scores — Demo

Compliance Progress — Demo

Regulatory Risk Register — Fictional Entries · Real Standard Citations

Risk ID	Description (Fictional)	RPN (Demo)	Real Standard	Mitigation Approach
RRN-1	FDA Pathway Misalignment	350	21 CFR 820.30 · Q-Sub Guidance	Q-Sub meeting, regulatory consultant
RRN-2	Clinical Evidence Inadequacy	420	21 CFR Part 814 PMA	Special Protocol Assessment, KOL panel
RRN-3	Quality System Non-Compliance	280	21 CFR 820 QSR	QSR gap analysis, mock inspections
RRN-4	Biocompatibility Evidence Gap	350	ISO 10993-1:2018	ISO 10993 matrix, FDA-recognized lab
CRN-3	Vision-Threatening Complication	490	ISO 14971 §7.5 Benefit-Risk	Enhanced positioning, optical quality testing

FDA Interaction Timeline — Fictional Demo

Meeting (Demo)	Date (Demo)	Objective	Real Standard Basis
Q-Sub #1	Feb 2026	Classification & Pathway	21 CFR 807 · FDA Q-Sub Guidance 2023
Q-Sub #2	Apr 2026	Clinical Protocol Alignment	21 CFR Part 812 IDE
PMA Submission	Q3 2027	Full PMA package	21 CFR Part 814
FDA Approval	Q4 2027	Commercial launch clearance	21 CFR 814.44

Team Resource Allocation — All Names & Contacts Are Fictional

⚠️ All team names, emails, roles, and RPN loads are entirely fictional demo data.

RPN Load per Demo Team Member

90-Day Budget Allocation — Demo

Resource Teams — Fictional Demo

Team (Demo)	Lead (Fictional)	Focus Risks	Timeline	Budget (Demo)
Alpha — Critical Materials	Demo Contact A	PRN-3, SRN-1, SRN-3	6-week sprint	$70,000
Beta — Design Optimization	Demo Contact B	PRN-1, PRN-5, SRN-1	8-week program	$45,000
Gamma — Validation	Demo Contact C	PRN-6, PrRN-2	12-week program	$35,000

Real-Time Alert System — Fictional Demo Data

⚠️ All alerts, risk IDs, owners, and due dates are fictional demo entries. Escalation protocols are based on real ISO 14971 and PMI Disciplined Agile best practices.

Priority	Risk ID	Alert (Fictional)	Owner (Fictional)	Due	Status	Action

Escalation Protocol — Real Risk Management Standards

Trigger	Escalation	Response Time	Standard Basis
Critical alert unacknowledged 2 hrs	→ Executive notification	2 hours	ISO 14971 §7.3 Risk Control
High alert unresolved 24 hrs	→ Management escalation	24 hours	21 CFR 820.100 CAPA
>20% variance from burndown	→ Project Director	Weekly review	PMI DA Risk Burndown
Budget overrun >$200K	→ Executive Level	Immediate	ISO 14971 §4.4 Risk Mgmt Plan

📋 Full Legal Disclaimer & Methodology Statement

⚠️ Section 1 — Fictional Data Notice

ALL DATA IN THIS DASHBOARD IS ENTIRELY FICTIONAL AND FOR DEMONSTRATION PURPOSES ONLY.
All business names, personnel names, product names, company names, contact details, risk scores, financial figures, timelines, and organizational information are fictional and do not represent any real product, medical device, company, enterprise, or individual. Any resemblance to actual persons, products, companies, or events is purely coincidental.

All risk IDs (PRN, SRN, PrRN, RRN, BRN, CRN series) and their descriptions, scores, and classifications
All personnel referenced as "Demo Contact A, B, C, D" and any prior fictional names
All email addresses, phone numbers, and contact information
All RPN scores, probability scores, impact scores, and financial figures
All timelines, deadlines, milestones, and project schedules
All budget figures, cost estimates, and financial projections

✅ Section 2 — PSP Methodology & Real Standards Statement

IMPORTANT DISTINCTION: While all risk data is entirely fictional, this dashboard was generated using the HigginsReports PSP (Product-Systems-Project) Risk Register methodology — a structured, standards-based framework that applies real assessments from published international standards. All standard citations are accurate and verifiable.

ISO 14971:2019 — Medical Device Risk Management

Third Edition. All §4–§10 citations in this dashboard are accurate references to this standard.

§4.4 Risk Mgmt Plan§5 Risk Analysis§7.5 Benefit-Risk§8 Residual Risk§9 Report§10 Post-Production

FDA 21 CFR Part 820 — Quality System Regulation

U.S. FDA QSR governing design, manufacture, packaging, and servicing of finished devices.

§820.30 Design Controls§820.50 Purchasing§820.75 Validation§820.100 CAPA§820.198 Complaints

ISO 11421:1997 — OTF Accuracy

Specifies accuracy of optical transfer function measurement. All §4 and §5 citations are accurate.

§4.5 Focus Error§4.6 Spatial Freq§4.7 Relay Optics§4.8 Spectral

ISO 10993 — Biocompatibility

Series of standards for evaluating the biocompatibility of medical devices.

ISO 10993-1:2018ISO 10993-5 CytotoxISO 10993-6 Implant

IEC 62366-1:2015 — Usability Engineering

Application of usability engineering to medical devices.

Formative EvaluationSummative EvaluationAnnex A Tasks

PMI Disciplined Agile — Risk Burndown

The 90-Day Plan burndown methodology is based on real PMI Disciplined Agile risk management principles.

PMI DA BurndownSprint-Based ReductionGate Reviews

🏢 Section 3 — About HigginsReports & Higgins.ai

Higgins.ai — Powerful · Personal · Private
This dashboard was generated by HigginsReports, a product of Higgins.ai — an enterprise AI platform powered by 101+ specialized AI models working in coordinated teams. Higgins.ai is a Delaware Public Benefit Corporation with patented technology (US9971979B2 & Provisional 63/794177) licensed by Google, Salesforce, and Slack. The PSP Risk Register methodology is a proprietary HigginsReports framework. Higgins.ai does not train models with your data, does not sell chats, and does not sell conversation learnings. Privacy is a core design pillar. Guaranteed 130% ROI in the first year or Higgins.ai absorbs the costs until you do.

Contact: contact@higgins.ai · Toll Free: 1.866.625.4524 · higgins.ai

⚖️ Section 4 — Limitation of Liability

This dashboard and all content are provided for demonstration and informational purposes only. HigginsReports and Higgins.ai make no representations or warranties regarding the completeness, accuracy, or reliability of the fictional data presented. Users should consult the official published versions of all cited standards and qualified regulatory professionals before applying any compliance frameworks to real medical device programs.

Demo Portfolio Overview — Fictional Data

🚨 Demo Critical Alerts — Fictional Data · Real Risk Patterns

Risk Distribution by Category (Demo)

Severity Breakdown (Demo)

Top 10 Risks by RPN — Demo

Standard Coverage — Real Standards · Demo Scores

Full Risk Register — Fictional Demo Entries · Sortable & Searchable

Risk Burndown Framework — PMI Disciplined Agile · Demo Data

Risk Score Burndown — Planned vs Actual 2026 (Demo)

Category Burndown Targets (Demo)

Phase Reduction Plan (Demo)