Structured clinical risk assessment and regulatory pathway guidance for digital health platforms, AI-enabled tools, and NHS-integrated systems.

Services include:
– Rapid clinical risk assessment and hazard identification
– MHRA regulatory classification and conformity assessment (UK market)
– DCB0129-aligned Clinical Safety Case Reports
– Clinical safety documentation for NHS procurement or investor due diligence
– Named Clinical Safety Officer (CSO) oversight and sign-off

Suitable for: Pre-submission readiness, NHS Digital compliance, MHRA pathway clarification, investor due diligence

Board-level clinical safety strategy, risk governance architecture, and AI risk management frameworks for regulated digital health organisations.

Services include:
– Clinical safety strategy design aligned to business milestones
– Risk governance framework (committees, escalation, reporting structures)
– Facilitated risk planning workshops with founders and clinical teams
– AI-specific risk management and algorithmic harm assessment
– Policy development (adverse event reporting, change control, safety escalation)

Suitable for: Early-stage governance build, institutional funding preparation, board risk oversight, regulatory positioning

Flexible advisory support and fractional clinical safety leadership for organisations requiring ongoing regulatory guidance or named accountability.

Services include:
– Monthly advisory retainer for ad-hoc regulatory queries and document review
– Fractional Chief Clinical Safety Officer (embedded senior role)
– Board-level safety reporting and regulatory interface management
– Short-notice consultation for investor meetings or regulatory queries

Suitable for: Ongoing regulatory guidance, live hazard log stewardship, board accountability, short-notice expert input