Company intelligence
Hardian Health
Software & AI as Medical Device consulting
About Hardian Health
We've helped over 150 software and AI medical devices get to market. 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 - Streamlined and agile FDA and CE/UKCA marking certification - Quality Management System design for software developers - 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 Got a regulatory problem? We can fix it! Newsletter: https://www.hardianhealth.com/newsletter Contact us: https://www.hardianhealth.com/contact
Verified activity
Signals from Hardian Health
4 published signals
Presence & Recognition
Hardian Health employee Dr Hugh Harvey will be at the launch of the Technology Working Group at the London Institute for Healthcare Engineering.
Reported by Hardian Health
Presence & Recognition
Hardian Health will attend the 2026 Mindset-XR Innovation in Mental Health Roadshow in London on Thursday, 10th September.
Reported by Hardian Health
Presence & Recognition
Hardian Health contributed to the stakeholder panel on medical device submission documentation.
Reported by Ben Howes
Research & Knowledge
Hardian Health published a blog by Lucy Rogers examining where MHRA clinical investigation applications commonly go wrong, why technical documentation matters earlier than many manufacturers expect, and how getting the foundations right can save months of regulatory rework later.
Reported by Hardian Health