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!

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Contact us: https://www.hardianhealth.com/contact

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