Company profile
Hardian Health
Software & AI as Medical Device consulting
- Industry
- Business Consulting and Services
- Employees
- 15
- Headquarters
- London, England
- Founded
- 2018
- LinkedIn followers
- 5,298
- Office locations
- 1
Hardian Health company summary
Hardian Health is a company in the Business Consulting and Services industry, headquartered in London, England, founded in 2018. On LinkedIn the company has around 15 employees and 5,298 followers. Its listed specialties include medical devices, SaMD, regulation, health economics, intellectual property.
What technology does Hardian Health use?
No technologies detected yet. Warmrank rechecks company websites on a rolling basis.
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
Specialties
Where is Hardian Health located?
Hardian Health lists 1 location.
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Frequently asked questions about Hardian Health
What does Hardian Health do?
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
How many employees does Hardian Health have?
Hardian Health has around 15 employees on LinkedIn.
Where is Hardian Health headquartered?
Hardian Health is headquartered in London, England.
When was Hardian Health founded?
Hardian Health was founded in 2018.
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