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TEF-Gateway

Consulting
Pricing/Discount Options: Call #2

Service Description

Comprehensive assessment of healthcare AI startups and SMEs across four readiness dimensions—technical, regulatory, organisational, and market—delivering a prioritised roadmap to close identified gaps.

The service includes: Technical Readiness Assessment Evaluation of AI model maturity, data pipeline robustness, validation status, deployment architecture, and scalability for clinical or production environments.

Regulatory Readiness Assessment Review of compliance posture against the EU AI Act, MDR requirements, GDPR obligations, and status of ethical approvals.

Organisational Readiness Assessment Assessment of team competencies, governance structures, quality management systems, and post-market surveillance capability.

Market Readiness Assessment Review of product-market fit, go-to-market strategy, reimbursement pathways, value proposition clarity, and competitive positioning.

Gap Analysis & Roadmap Structured mapping of gaps between current and target state across all dimensions, with prioritised recommendations, indicative timelines, and a follow-up session.

Keywords: Gap Analyses regulatory preparedness matchmaking
Offerings: Business (market readiness, monitoring, feasibility, etc.)
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Provider & Contact

Provider Organisation Karolinska Institutet (KI)
Provider Country Sweden
Organisation Website https://ki.se
Billing: per project
Full Price €2000 EUR
Reduced Price €Free

Operational Details

Service Inputs Description of the AI solution and intended clinical application Company information including team composition, development stage, and strategic objectives Supporting documentation: product specifications, business plans, regulatory strategy, quality management documents Access to key team members for structured interviews
Service Outputs Comprehensive gap analysis report covering all four readiness dimensions Visual summaries of current state, target state, and identified gaps Prioritised roadmap with recommended actions and indicative timelines Findings presentation and follow-up session
Dependencies & Restrictions Quality of assessment depends on completeness and accuracy of information provided Does not constitute formal regulatory advice, legal counsel, or investment guidance Execution responsibility remains with the company Assessment is qualitative and expert-driven; does not include hands-on development, coding, or regulatory filing preparation