NeuroPathway Readiness Checklist

Complete path to market-ready licensing

Overall Progress
0 of 75 items completed (0 in progress)
0
Completed
0
In Progress
75
Not Started
Total Estimated Investment:£115k - £325k

Investment timeline: 18 months to full market readiness

Regulatory & Clinical Safety (MHRA)
Phase 3 (Months 7-12)
0/8 Complete

MHRA Medical Device Registration

critical

Register NeuroPathway as Class IIa medical device under UK MDR 2002

£30k-£80k
6-9 months

Clinical Safety Case (DCB0129)

critical

Document all clinical risks, hazards, and mitigation strategies

£15k-£30k
2-3 months

Clinical Risk Management (DCB0160)

critical

Establish ongoing hazard monitoring and incident reporting processes

£10k-£20k
2-3 months
Dependencies: reg-2

UKCA Marking Application

critical

Apply for UKCA marking (required for UK market)

£5k-£15k
3-6 months
Dependencies: reg-1, reg-2

AI Model Documentation

critical

Document training data, validation metrics, bias testing per MHRA ML principles

£10k-£25k
2-4 months

Predetermined Change Control Plans

high

Create ML update and change control documentation

£5k-£10k
1-2 months
Dependencies: reg-5

Technical File Compilation

critical

Assemble complete technical file with design specs, risk analysis, clinical evaluation

£8k-£15k
2-3 months
Dependencies: reg-1, reg-2, reg-5

Notified Body Assessment

critical

Engage UK-approved notified body for conformity assessment

£15k-£40k
3-6 months
Dependencies: reg-7, reg-4
Phase Timeline Overview
Key milestones and dependencies

Phase 1: Foundation (Months 1-3)

Focus: DPIA, DSPT compliance, insurance, clinical safety case, security audits

Investment: £25k-£65k

Phase 2: Validation (Months 4-6)

Focus: NHS/school pilots, clinical validation, user testing, AI bias audit

Investment: £40k-£95k

Phase 3: Regulatory (Months 7-12)

Focus: MHRA submission, NHS Digital API access, NICE evidence, ISO 27001

Investment: £50k-£125k

Phase 4: Launch (Months 12-18)

Focus: NHS App Library, commercial contracts, scale infrastructure, marketing

Investment: £15k-£40k + ongoing costs
Critical Path Items (Must Complete First)
These items block other tasks and should be prioritized
MHRA Medical Device Registration
Critical6-9 months
Clinical Safety Case (DCB0129)
Critical2-3 months
Clinical Risk Management (DCB0160)
Critical2-3 months
UKCA Marking Application
Critical3-6 months
AI Model Documentation
Critical2-4 months
Technical File Compilation
Critical2-3 months
Notified Body Assessment
Critical3-6 months
Data Protection Impact Assessment (DPIA)
Critical1-2 months
Appoint Data Protection Officer (DPO)
Critical1 month
Privacy Notices for All User Types
Critical2-3 weeks
Data Security & Protection Toolkit (DSPT)
Critical2-3 months
NHS Digital Developer Portal Registration
Critical1-2 weeks
BaRS API Access Application
Critical2-4 months
PDS FHIR API Access Application
Critical2-4 months
FHIR Conformance Testing
Critical2-3 months
NHS Data Sharing Agreements
Critical1-2 months
NHS Trust Pilot Partnerships (2-3 trusts)
Critical3-6 months
Clinical Validation Study
Critical6-12 months
AI Bias Audit
Critical2-4 months
NHS Research Ethics Committee Approval
Critical2-3 months
End User License Agreement (EULA)
Critical2-3 weeks
NHS Trust License Agreement
Critical1 month
Data Processing Agreement (DPA)
Critical2-3 weeks
Clinical Responsibility Framework
Critical1 month
Terms of Service
Critical2-3 weeks
Professional Indemnity Insurance
Critical1 month
99.9% Uptime Infrastructure
Critical1-2 months
Backup & Disaster Recovery
Critical1 month
Independent Security Audit
Critical1-2 months
Penetration Testing
Critical1 month
WCAG 2.1 AA Accessibility Audit
Critical1-2 months