Hardian Health

We help researchers, industry and investors bring digital solutions to healthcare. Harness regulatory and market access excellence through our consultancy services by experienced consultants and clinicians within the Software as a Medical Device (SaMD) and AI as a Medical Device (AIaMD) industry. We are a full stack consultancy: - Target Product Profiling and Value Propositions - FDA and CE/UKCA marking certification - Quality Management System design, development and deployment - Support against all ISO & IEC standards (13485, 14155, 14971, 62304, 82304, 27001, 42001 and more...) - Trained ISO auditors - mock audits and internal/external audit preparations - Notified Body and FDA engagement - Health economic modelling - budget impact and cost-effectiveness/cost-utility - Market access strategy and competitor analysis - Clinical evidence, clinical validation and post market clinical follow up - UKRP and PRRC functions - Intellectual property management - Investor due diligence Newsletter: https://www.hardianhealth.com/newsletter Contact us: https://www.hardianhealth.com/contact